{"protocolSection":{"identificationModule":{"nctId":"NCT05671653","orgStudyIdInfo":{"id":"C3991040"},"secondaryIdInfos":[{"id":"NCT05671653","type":"REGISTRY","domain":"ClinicalTrials.gov"}],"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"A Study to Evaluate the Effect of the Experimental GLP-1 Drug PF-07081532 on Blood Levels of Common Birth Control Pills, and Drugs Omeprazole and Midazolam, and Effect of GLP-1 Drug Semaglutide on Midazolam Blood Levels in Healthy Adults With Weight in the Obesity Range","officialTitle":"A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE EFFECT OF TWO STEADY-STATE DOSE LEVELS OF PF-07081532 ON THE PHARMACOKINETICS OF SINGLE-DOSE MIDAZOLAM, OMEPRAZOLE AND AN ORAL CONTRACEPTIVE, AND THE EFFECT OF STEADY-STATE SEMAGLUTIDE ON THE PHARMACOKINETICS OF SINGLE-DOSE MIDAZOLAM, IN OBESE ADULT FEMALE PARTICIPANTS"},"statusModule":{"statusVerifiedDate":"2025-01","overallStatus":"TERMINATED","whyStopped":"The decision to terminate clinical development of lotiglipron is based on pharmacokinetic data from Phase 1 drug-drug-interaction studies and laboratory measurements of elevated transaminases in these Phase 1 studies as well as a Phase 2 study.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2023-01-19","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-11-03","type":"ACTUAL"},"completionDateStruct":{"date":"2023-11-03","type":"ACTUAL"},"studyFirstSubmitDate":"2022-12-19","studyFirstSubmitQcDate":"2023-01-03","studyFirstPostDateStruct":{"date":"2023-01-05","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-10-28","resultsFirstSubmitQcDate":"2024-10-28","resultsFirstPostDateStruct":{"date":"2024-12-16","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-01-06","lastUpdatePostDateStruct":{"date":"2025-01-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Two different groups of healthy volunteers will be chronically treated with GLP-1 drugs PF-07081532 or alternatively Semaglutide. The effect of these GLP-1 drugs on a single dose of the common sedative medication midazolam blood levels will be measured. The effect of chronic PF-07081532 on single doses of the common stomach acid medication omeprazole, and common birth control medication blood levels will also be measured. The hypothesis is that chronic administration of the GLP-1 drugs will minimally affect blood levels from these common medications."},"conditionsModule":{"conditions":["Obesity"],"keywords":["Midazolam","Omeprazole","PF-07081532"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","interventionModelDescription":"The overall design is randomized, open-label, fixed-sequence. Cohort 1 will consist of 9 periods while Cohort 2 will consist of 4 periods.","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":32,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Cohort 1: PF-07081532","type":"EXPERIMENTAL","description":"Cohort 1 is an open-label, 9 period, fixed-sequence design to evaluate the effect of 2 steady state dose levels of PF-07081532 on the SD pharmacokinetics of midazolam and omeprazole, administered simultaneously, and an OC (LE/EE) in otherwise healthy obese adult female participants with a BMI ≥30 kg/m2.","interventionNames":["Drug: PF-07081532"]},{"label":"Cohort 2: Semaglutide","type":"EXPERIMENTAL","description":"Cohort 2 is an open label, 4-period, fixed-sequence design to evaluate the effect of steady state semaglutide on the SD PK of midazolam in obese adult female participants with a BMI ≥30 kg/m2","interventionNames":["Drug: Semaglutide"]}],"interventions":[{"type":"DRUG","name":"PF-07081532","description":"Experimental oral GLP-1 drug","armGroupLabels":["Cohort 1: PF-07081532"]},{"type":"DRUG","name":"Semaglutide","description":"Approved and marketed GLP-1 drug for subcutaneous injection.","armGroupLabels":["Cohort 2: Semaglutide"],"otherNames":["Wegovy, Ozempic"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Cohort 1: Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Midazolam in Periods 1, 4 and 7","description":"Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 1: Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Omeprazole in Periods 1, 4 and 7","description":"Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. AUClast calculated area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 1: AUClast of Levonorgestrel (LE) in Periods 2, 5,and 8","description":"LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. AUClast calculated area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period"},{"measure":"Cohort 1: AUCinf of Ethinyl Estradiol (EE) in Periods 2, 5,and 8","description":"EE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for EE PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to EE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period"},{"measure":"Cohort 2: AUCinf of Midazolam in Period 1 and 3","description":"Midazolam was given on Day 1 in Period 1 and 3 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.","timeFrame":"For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"}],"secondaryOutcomes":[{"measure":"Cohort 1: Number of Participants With All-Causality and Treatment-Related TEAEs","description":"An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were events between first dose of study treatment and up to approximately 35 days that were absent before treatment or that worsened relative to pretreatment state.","timeFrame":"From first dose (Day 1) to follow-up telephone contact (Days 153 to 160) in Cohort 1"},{"measure":"Cohort 1: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)","description":"Laboratory tests (including hematology, clinical chemistry, urinalysis) were reported and abnormalities were defined for laboratory values that met specific criteria.","timeFrame":"From first dose (Day 1) to follow-up telephone contact (Days 153 to 160) in Cohort 1"},{"measure":"Cohort 1: Percentage of Change From Baseline in Body Weight by Period 9 Day 1","description":"Percentage of changes from Baseline in body weight of the participants were measured.","timeFrame":"From baseline (last pre-dose measurement in Period 1) to Period 9 Day 1 (Day 124)"},{"measure":"Cohort 1: Number of Participants With Completed Suicide, Suicide Attempt, Preparatory Acts Towards Imminent Suicidal Behavior, Suicidal Ideation, or Self-Injurious Behavior of No Suicidal Intent As Assessed on the C-SSRS","description":"The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS items were mapped to the following categories: completed suicide, suicide attempt, preparatory acts towards imminent suicidal behavior, suicidal ideation, and self-injurious behavior of no suicidal intent. Number of participants with completed suicide, suicide attempt, preparatory acts towards imminent suicidal behavior, suicidal ideation, or self-injurious behavior of no suicidal intent as assessed on the C-SSRS are reported below.","timeFrame":"Screening, Study Day -1 (D-1) (ie, Period 1 Day -1 [P1D-1]), D7 (P3D1), D21 (P3D15), D35 (P4D1), D54 (P6D14), D68 (P6D28), D82 (P6D42), D96 (P6D56), D103 (P6D63), D110 (P8D6) and at follow up visit D132-135"},{"measure":"Cohort 1: Patient Health Quessionare-9 (PHQ-9) Total Scores","description":"The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The PHQ-9 is completed by participants and reviewed by site staff at the pre-defined time points. The total score is derived by adding the corresponding values of responses to each item. The total score ranges from 0 to 27, with the following interpretation: 1-4: Minimal depression; 5-9: Mild depression; 10-14: Moderate depression; 15-19: Moderately severe depression; 20-27: Severe depression.","timeFrame":"Screening, Study Day -1 (D-1) (ie, Period 1 Day -1 [P1D-1]), D7 (P3D1), D21 (P3D15), D35 (P4D1), D54 (P6D14), D68 (P6D28), D82 (P6D42), D96 (P6D56), D103 (P6D63), D110 (P8D6) and at follow up visit D132-135"},{"measure":"Cohort 1: AUCinf of Midazolam in Period 9","description":"Midazolam was given on Day 1 in Period 9 of Cohort 1 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.","timeFrame":"For Cohort 1 Period 9: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1"},{"measure":"Cohort 1: Maximum Observed Concentration (Cmax) of Midazolam in Period 1, 4, 7","description":"Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 1: Time for Cmax (Tmax) of Midazolam in Period 1, 4, 7","description":"Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. Tmax was defined as time for Cmax and was observed directly from data.","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 1: Apparent Clearance (CL/F) of Midazolam in Period 1, 4, 7","description":"Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. CL/F was defined as apparent clearance and was calculated as dose/AUCinf.","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 1: Apparent Volume of Distribution (Vz/F) of Midazolam in Period 1, 4, 7","description":"Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf\\*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 1: Terminal Half-Life (t1/2) of Midazolam in Period 1, 4, 7","description":"Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. t1/2 was defined as terminal half life and was calculated as loge(2)/kel.","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 1: Cmax of Omeprazole in Period 1, 4, 7","description":"Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 1: Tmax of Omeprazole in Period 1, 4, 7","description":"Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. Tmax was defined as time for Cmax and was observed directly from data.","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 1: CL/F of Omeprazole in Period 1, 4, 7","description":"Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. CL/F was defined as apparent clearance and was calculated as dose/AUCinf.","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 1: Vz/F of Omeprazole in Period 1, 4, 7","description":"Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf\\*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 1: t1/2 of Omeprazole in Period 1, 4, 7","description":"Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf ×kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 1: Cmax of LE in Period 2, 5, 8","description":"LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period"},{"measure":"Cohort 1: Tmax of LE in Period 2, 5, 8","description":"LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period"},{"measure":"Cohort 1: CL/F of LE in Period 2, 5, 8","description":"LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period"},{"measure":"Cohort 1: Vz/F of LE in Period 2, 5, 8","description":"LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf\\*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period"},{"measure":"Cohort 1: t1/2 of LE in Period 2, 5, 8","description":"LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. t1/2 was defined as terminal half life and was calculated as loge(2)/kel.","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period"},{"measure":"Cohort 1: Cmax of EE in Period 2, 5, 8","description":"EE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for EE PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to EE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period"},{"measure":"Cohort 1: Tmax of EE in Period 2, 5, 8","description":"EE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for EE PK at the preset time points described in the Time Frame. Tmax was defined as time for Cmax and was observed directly from data.","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to EE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period"},{"measure":"Cohort 1: CL/F of EE in Period 2, 5, 8","description":"EE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for EE PK at the preset time points described in the Time Frame. CL/F was defined as apparent clearance and was calculated as dose/AUCinf.","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to EE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period"},{"measure":"Cohort 1: Vz/F of EE in Period 2, 5, 8","description":"EE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for EE PK at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf\\*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to EE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period"},{"measure":"Cohort 1: t1/2 of EE in Period 2, 5, 8","description":"EE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for EE PK at the preset time points described in the Time Frame. t1/2 was defined as terminal half life and was calculated as loge(2)/kel.","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to EE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period"},{"measure":"Cohort 1: Metabolite/Parent Ratio for AUCinf (MRAUCinf) of 1-Hydroxy Midazolam in Period 1, 4, 7","description":"Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam (parent) and and its metabolite 1-Hydroxy Midazolam PK at the preset time points described in the Time Frame. MRAUCinf was calculated as (AUCinf, metabolite/AUCinf, parent) \\* (MWparent/MWmetabolite). MW = molecular weight.","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 1: MRAUCinf of 5-Hydroxy Omeprazole in Period 1, 4, 7","description":"Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole (parent) and and its metabolite 5-Hydroxy omeprazole PK at the preset time points described in the Time Frame. MRAUCinf was calculated as (AUCinf, metabolite/AUCinf, parent) \\* (MWparent/MWmetabolite). MW = molecular weight.","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 1: Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of PF-07081532 in Period 3 and 6","description":"PF-07081532 was given titrated to 80 mg QD on Day 1-28 of Period 3, and titrated to 260 mg QD on Day 1-63 of Period 6 in Cohort 1, and blood samples were collected for PF-07081532 PK at the preset time points described in the Time Frame. AUC24 was defined as area under the plasma concentration-time profile from time 0 to 24 hours and was determined using the linear/log trapezoidal method.","timeFrame":"For Cohort 1 Periods 3 and 6: At 0 , 0.5, 1, 2, 4, 6, 8, 10, 14, and 24 hours post PF-07081532 dose on Day 28 of Period 3 and Day 63 of Period 6"},{"measure":"Cohort 1: Cmax of PF-07081532 in Period 3 and 6","description":"PF-07081532 was given titrated to 80 mg QD on Day 1-28 of Period 3, and titrated to 260 mg QD on Day 1-63 of Period 6 in Cohort 1, and blood samples were collected for PF-07081532 PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","timeFrame":"For Cohort 1 Periods 3 and 6: At 0 , 0.5, 1, 2, 4, 6, 8, 10, 14, and 24 hours post PF-07081532 dose on Day 28 of Period 3 and Day 63 of Period 6"},{"measure":"Cohort 1: Tmax of PF-07081532 in Period 3 and 6","description":"PF-07081532 was given titrated to 80 mg QD on Day 1-28 of Period 3, and titrated to 260 mg QD on Day 1-63 of Period 6 in Cohort 1, and blood samples were collected for PF-07081532 PK at the preset time points described in the Time Frame. Tmax was defined as time for Cmax and was observed directly from data.","timeFrame":"For Cohort 1 Periods 3 and 6: At 0 , 0.5, 1, 2, 4, 6, 8, 10, 14, and 24 hours post PF-07081532 dose on Day 28 of Period 3 and Day 63 of Period 6"},{"measure":"Cohort 2: Number of Participants With All-Causality and Treatment-Related TEAEs","description":"An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were events between first dose of study treatment and up to approximately 35 days that were absent before treatment or that worsened relative to pretreatment state.","timeFrame":"From first dose (Day 1) to follow-up telephone contact (Days 193 to 200) in Cohort 2"},{"measure":"Cohort 2: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)","description":"Laboratory tests (including hematology, clinical chemistry, urinalysis) were reported and abnormalities were defined for laboratory values that met specific criteria.","timeFrame":"From first dose (Day 1) to follow-up telephone contact (Days 193 to 200) in Cohort 2"},{"measure":"Cohort 2: Percentage of Change From Baseline in Body Weight by Period 4 Day 1","description":"Percentage of changes from Baseline in body weight of the participants were measured.","timeFrame":"From baseline (last pre-dose measurement in Period 1) to Period 4 Day 1 (Day 165)"},{"measure":"Cohort 2: Number of Participants With Completed Suicide, Suicide Attempt, Preparatory Acts Towards Imminent Suicidal Behavior, Suicidal Ideation, or Self-Injurious Behavior of No Suicidal Intent As Assessed on the C-SSRS","description":"The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS items were mapped to the following categories: completed suicide, suicide attempt, preparatory acts towards imminent suicidal behavior, suicidal ideation, and self-injurious behavior of no suicidal intent. Number of participants with completed suicide, suicide attempt, preparatory acts towards imminent suicidal behavior, suicidal ideation, or self-injurious behavior of no suicidal intent as assessed on the C-SSRS are reported below.","timeFrame":"Screening, D-1 (P1D-1), P2 Week 5 [W5], P2W9, P2W13, P2W17, D150 (P3D2), at follow up visit (Day 172-175)"},{"measure":"Cohort 2: PHQ-9 Total Scores","description":"The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The PHQ-9 is completed by participants and reviewed by site staff at the pre-defined time points. The total score is derived by adding the corresponding values of responses to each item. The total score ranges from 0 to 27, with the following interpretation: 1-4: Minimal depression; 5-9: Mild depression; 10-14: Moderate depression; 15-19: Moderately severe depression; 20-27: Severe depression.","timeFrame":"Screening, D-1 (P1D-1), P2 Week 5 [W5], P2W9, P2W13, P2W17, D150 (P3D2), at follow up visit (Day 172-175)"},{"measure":"Cohort 2: AUCinf of Midazolam in Period 4","description":"Midazolam was given on Day 1 in Period 4 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.","timeFrame":"For Cohort 2 Period 4: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14 and 24 hours post midazolam dose on Day 1"},{"measure":"Cohort 2: Cmax of Midazolam in Period 1 and 3","description":"Midazolam was given on Day 1 in Period 1 and 3 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","timeFrame":"For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 2: Tmax of Midazolam in Period 1 and 3","description":"Midazolam was given on Day 1 in Period 1 and 3 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. Tmax was defined as time for Cmax and was observed directly from data.","timeFrame":"For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 2: CL/F of Midazolam in Period 1 and 3","description":"Midazolam was given on Day 1 in Period 1 and 3 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. CL/F was defined as apparent clearance and was calculated as dose/AUCinf.","timeFrame":"For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 2: Vz/F of Midazolam in Period 1 and 3","description":"Midazolam was given on Day 1 in Period 1 and 3 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf\\*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.","timeFrame":"For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 2: t1/2 of Midazolam in Period 1 and 3","description":"Midazolam was given on Day 1 in Period 1 and 3 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. t1/2 was defined as terminal half life and was calculated as loge(2)/kel.","timeFrame":"For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"},{"measure":"Cohort 2: MRAUCinf of 1-Hydroxy Midazolam in Period 1, 3, 4","description":"Midazolam was given on Day 1 in Period 1, 3, 4 of Cohort 2 and blood samples were collected for midazolam (parent) and and its metabolite 1-Hydroxy Midazolam PK at the preset time points described in the Time Frame. MRAUCinf was calculated as (AUCinf, metabolite/AUCinf, parent) \\* (MWparent/MWmetabolite). MW = molecular weight.","timeFrame":"For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Healthy (no clinically relevant abnormalities)\n* BMI 30.0-45.4 inclusive\n\nExclusion Criteria:\n\n* Current or history of significant clinical condition\n* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 or 14 days or 5 half-lives (whichever is longer)\n* Pregnant\n* Breast feeding","healthyVolunteers":true,"sex":"FEMALE","genderBased":true,"minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Anaheim Clinical Trials, LLC","city":"Anaheim","state":"California","zip":"92801","country":"United States","geoPoint":{"lat":33.83529,"lon":-117.9145}}]},"referencesModule":{"references":[{"pmid":"42053447","type":"DERIVED","citation":"Cronenberger C, Amin NB, Le VH, Carvajal-Gonzalez S, Ashworth AL, Yi EC, Schuster T, Zhang Y, Frederich RC, Friedman GS, Wang EQ, Tsamandouras N. Assessment of the Drug-Drug Interaction Potential of Lotiglipron (PF-07081532) with Midazolam, Omeprazole, Dabigatran, Rosuvastatin, and the Oral Contraceptives Levonorgestrel and Ethinyl Estradiol. J Clin Pharmacol. 2026 May;66(5):e70158. doi: 10.1002/jcph.70158."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://pmiform.com/clinical-trial-info-request?StudyID=C3991040"}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"This study was a Phase 1, open-label, fixed-sequence study conducted with 2 cohorts. 16 participants were enrolled in Cohort 1 with 9 periods, 16 participants were enrolled in Cohort 2 with 4 periods.","groups":[{"id":"FG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"FG001","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"FG002","title":"Cohort 1: PF-07081532 Titration up to 80 mg QD (Period 3)","description":"Participants in Cohort 1 received PF-07081532 20 mg once daily (QD) on Day 1-7, 40 mg QD on Day 8-14, 60 mg QD on Day 15-21, 80 mg QD on Day 22-28 of Period 3."},{"id":"FG003","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"FG004","title":"Cohort 1: PF-07081532 80 mg QD+ LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"FG005","title":"Cohort 1: PF-07081532 Titration up to 260 mg QD (Period 6)","description":"Participants in Cohort 1 received PF-07081532 100 mg QD on Day 1-7, 120 mg QD on DAY 8-14, 140 mg QD on Day 15-21, 160 mg QD on Day 22-28, 180 mg QD on Day 29-35, 200 mg QD on Day 36-42, 220 mg QD on Day 43-49, 240 mg QD on Day 50-56, 260 mg QD on Day 57-63 of Period 6."},{"id":"FG006","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."},{"id":"FG007","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."},{"id":"FG008","title":"Cohort 1: Midazolam 2 mg (Period 9)","description":"Participants in Cohort 1 received SD of midazolam 2 mg on Day 1 of Period 9."},{"id":"FG009","title":"Cohort 2: Midazolam 2 mg (Period 1)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 1."},{"id":"FG010","title":"Cohort 2: Semaglutide Titration up to 2.4 mg QW (Period 2)","description":"Participants in Cohort 2 received semaglutide 0.25 mg once weekly (QW) on Week 1-4, 0.5 mg QW on Week 5-8, 1.0 mg QW on Week 9-12, 1.7 mg QW on Week 13-16, 2.4 mg QW on Week 17-21 of Period 2."},{"id":"FG011","title":"Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3)","description":"Participants in Cohort 2 received semaglutide 2.4 mg QW and SD of midazolam 2 mg on Day 1 of Period 3."},{"id":"FG012","title":"Cohort 2: Midazolam 2 mg (Period 4)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 4."}],"periods":[{"title":"Cohort 1 Period 1 - Treatment","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG002","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG003","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG004","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG005","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG006","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG007","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG008","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG009","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG010","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG011","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG012","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG002","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG003","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG004","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG005","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG006","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG007","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG008","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG009","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG010","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG011","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"},{"groupId":"FG012","comment":"This period only applies to the group \"Cohort 1 Period 1\".","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"},{"groupId":"FG011","numSubjects":"0"},{"groupId":"FG012","numSubjects":"0"}]}]},{"title":"Cohort 1 Period 2 - Treatment","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG003","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG004","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG005","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG006","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG007","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG008","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG009","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG010","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG011","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG012","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG003","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG004","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG005","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG006","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG007","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG008","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG009","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG010","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG011","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"},{"groupId":"FG012","comment":"This period only applies to the group \"Cohort 1 Period 2\".","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"},{"groupId":"FG011","numSubjects":"0"},{"groupId":"FG012","numSubjects":"0"}]}]},{"title":"Cohort 1 Period 3 - Treatment","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG001","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG002","numSubjects":"16"},{"groupId":"FG003","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG004","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG005","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG006","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG007","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG008","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG009","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG010","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG011","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG012","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG001","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG002","numSubjects":"16"},{"groupId":"FG003","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG004","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG005","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG006","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG007","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG008","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG009","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG010","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG011","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"},{"groupId":"FG012","comment":"This period only applies to the group \"Cohort 1 Period 3\".","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"},{"groupId":"FG011","numSubjects":"0"},{"groupId":"FG012","numSubjects":"0"}]}]},{"title":"Cohort 1 Period 4 - Treatment","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG001","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG002","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG003","numSubjects":"16"},{"groupId":"FG004","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG005","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG006","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG007","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG008","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG009","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG010","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG011","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG012","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG001","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG002","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG003","numSubjects":"16"},{"groupId":"FG004","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG005","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG006","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG007","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG008","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG009","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG010","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG011","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"},{"groupId":"FG012","comment":"This period only applies to the group \"Cohort 1 Period 4\".","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"},{"groupId":"FG011","numSubjects":"0"},{"groupId":"FG012","numSubjects":"0"}]}]},{"title":"Cohort 1 Period 5 - Treatment","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG001","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG002","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG003","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG004","numSubjects":"16"},{"groupId":"FG005","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG006","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG007","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG008","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG009","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG010","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG011","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG012","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG001","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG002","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG003","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG004","numSubjects":"16"},{"groupId":"FG005","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG006","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG007","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG008","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG009","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG010","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG011","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"},{"groupId":"FG012","comment":"This period only applies to the group \"Cohort 1 Period 5\".","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"0"},{"groupId":"FG011","numSubjects":"0"},{"groupId":"FG012","numSubjects":"0"}]}]},{"title":"Cohort 1 Period 6 - Treatment","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"This period only applies to the group \"Cohort 1 Period 6\".","numSubjects":"0"},{"groupId":"FG001","comment":"This period only applies to the group \"Cohort 1 Period 6\".","numSubjects":"0"},{"groupId":"FG002","comment":"This period only applies to the group \"Cohort 1 Period 6\".","numSubjects":"0"},{"groupId":"FG003","comment":"This period only applies to the group \"Cohort 1 Period 6\".","numSubjects":"0"},{"groupId":"FG004","comment":"This period only applies to the group \"Cohort 1 Period 6\".","numSubjects":"0"},{"groupId":"FG005","numSubjects":"16"},{"groupId":"FG006","comment":"This period only applies to the group \"Cohort 1 Period 6\".","numSubjects":"0"},{"groupId":"FG007","comment":"This period only applies to the group \"Cohort 1 Period 6\".","numSubjects":"0"},{"groupId":"FG008","comment":"This period only applies to the group \"Cohort 1 Period 6\".","numSubjects":"0"},{"groupId":"FG009","comment":"This period only applies to the group \"Cohort 1 Period 6\".","numSubjects":"0"},{"groupId":"FG010","comment":"This period only applies to the group \"Cohort 1 Period 6\".","numSubjects":"0"},{"groupId":"FG011","comment":"This period only applies to the group \"Cohort 1 Period 6\".","numSubjects":"0"},{"groupId":"FG012","comment":"This period only applies to the group \"Cohort 1 Period 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Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"1"},{"groupId":"FG011","numSubjects":"0"},{"groupId":"FG012","numSubjects":"0"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"},{"groupId":"FG007","numSubjects":"0"},{"groupId":"FG008","numSubjects":"0"},{"groupId":"FG009","numSubjects":"0"},{"groupId":"FG010","numSubjects":"1"},{"groupId":"FG011","numSubjects":"0"},{"groupId":"FG012","numSubjects":"0"}]}]},{"title":"Cohort 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Latino","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"11"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"21"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"17"}]}]},{"title":"Black or African 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AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram*hour/milliliter (ng*hr/mL)","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39.27","spread":"33"},{"groupId":"OG001","value":"33.30","spread":"37"},{"groupId":"OG002","value":"28.23","spread":"49"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4).","nonInferiorityType":"OTHER","nonInferiorityComment":"Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.","paramType":"Ratio (%) of Adjusted Geometric Means","paramValue":"88.85","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"80.25","ciUpperLimit":"98.38"},{"groupIds":["OG000","OG002"],"groupDescription":"Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7).","nonInferiorityType":"OTHER","nonInferiorityComment":"Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.","paramType":"Ratio (%) of Adjusted Geometric Means","paramValue":"70.00","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"55.21","ciUpperLimit":"88.76"}]},{"type":"PRIMARY","title":"Cohort 1: Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Omeprazole in Periods 1, 4 and 7","description":"Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. AUClast calculated area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.","populationDescription":"Participants who received at least 1 dose of omeprazole, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng*hr/mL","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"956.3","spread":"90"},{"groupId":"OG001","value":"620.5","spread":"174"},{"groupId":"OG002","value":"602.8","spread":"154"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4).","nonInferiorityType":"OTHER","nonInferiorityComment":"Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.","paramType":"Ratio (%) of Adjusted Geometric Means","paramValue":"57.19","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"39.27","ciUpperLimit":"83.29"},{"groupIds":["OG000","OG002"],"groupDescription":"Reference: Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1). Test: Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7).","nonInferiorityType":"OTHER","nonInferiorityComment":"Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.","paramType":"Ratio (%) of Adjusted Geometric Means","paramValue":"29.68","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"19.60","ciUpperLimit":"44.94"}]},{"type":"PRIMARY","title":"Cohort 1: AUClast of Levonorgestrel (LE) in Periods 2, 5,and 8","description":"LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. AUClast calculated area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.","populationDescription":"Participants who received at least 1 dose of LE, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"picogram*hour/milliliter (pg*hr/mL)","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"31360","spread":"52"},{"groupId":"OG001","value":"42120","spread":"56"},{"groupId":"OG002","value":"60020","spread":"63"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Reference: Cohort 1: LE 0.15 mg \\& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg \\& EE 0.03 mg (Period 5).","nonInferiorityType":"OTHER","nonInferiorityComment":"Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.","paramType":"Ratio (%) of Adjusted Geometric Means","paramValue":"119.86","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"108.97","ciUpperLimit":"131.85"},{"groupIds":["OG000","OG002"],"groupDescription":"Reference: Cohort 1: LE 0.15 mg \\& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg \\& EE 0.03 mg (Period 8)","nonInferiorityType":"OTHER","nonInferiorityComment":"Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.","paramType":"Ratio (%) of Adjusted Geometric Means","paramValue":"185.45","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"108.00","ciUpperLimit":"318.44"}]},{"type":"PRIMARY","title":"Cohort 1: AUCinf of Ethinyl Estradiol (EE) in Periods 2, 5,and 8","description":"EE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for EE PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.","populationDescription":"Participants who received at least 1 dose of EE, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"pg*hr/mL","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to EE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"754.5","spread":"37"},{"groupId":"OG001","value":"765.5","spread":"26"},{"groupId":"OG002","value":"701.1","spread":"29"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Reference: Cohort 1: LE 0.15 mg \\& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg \\& EE 0.03 mg (Period 5).","nonInferiorityType":"OTHER","nonInferiorityComment":"Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.","paramType":"Ratio (%) of Adjusted Geometric Means","paramValue":"103.17","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"95.09","ciUpperLimit":"111.93"},{"groupIds":["OG000","OG002"],"groupDescription":"Reference: Cohort 1: LE 0.15 mg \\& EE 0.03 mg (Period 2). Test: Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg \\& EE 0.03 mg (Period 8)","nonInferiorityType":"OTHER","nonInferiorityComment":"Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.","paramType":"Ratio (%) of Adjusted Geometric Means","paramValue":"90.20","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"60.24","ciUpperLimit":"135.06"}]},{"type":"PRIMARY","title":"Cohort 2: AUCinf of Midazolam in Period 1 and 3","description":"Midazolam was given on Day 1 in Period 1 and 3 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng*hr/mL","timeFrame":"For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 2: Midazolam 2 mg (Period 1)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3)","description":"Participants in Cohort 2 received semaglutide 2.4 mg QW and SD of midazolam 2 mg on Day 1 of Period 3."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"34.43","spread":"43"},{"groupId":"OG001","value":"34.60","spread":"48"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Reference: Cohort 2: Midazolam 2 mg (Period 1). Test: Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3).","nonInferiorityType":"OTHER","nonInferiorityComment":"Analysis done using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. Ratio (Test/Reference) and 90% confidence interval (CI) are expressed as percentages.","paramType":"Ratio (%) of Adjusted Geometric Means","paramValue":"92.88","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"79.97","ciUpperLimit":"107.87"}]},{"type":"SECONDARY","title":"Cohort 1: Number of Participants With All-Causality and Treatment-Related TEAEs","description":"An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were events between first dose of study treatment and up to approximately 35 days that were absent before treatment or that worsened relative to pretreatment state.","populationDescription":"All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From first dose (Day 1) to follow-up telephone contact (Days 153 to 160) in Cohort 1","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"OG002","title":"Cohort 1: PF-07081532 Titration up to 80 mg QD (Period 3)","description":"Participants in Cohort 1 received PF-07081532 20 mg once daily (QD) on Day 1-7, 40 mg QD on Day 8-14, 60 mg QD on Day 15-21, 80 mg QD on Day 22-28 of Period 3."},{"id":"OG003","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG004","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"OG005","title":"Cohort 1: PF-07081532 Titration up to 260 mg QD (Period 6)","description":"Participants in Cohort 1 received PF-07081532 100 mg QD on Day 1-7, 120 mg QD on DAY 8-14, 140 mg QD on Day 15-21, 160 mg QD on Day 22-28, 180 mg QD on Day 29-35, 200 mg QD on Day 36-42, 220 mg QD on Day 43-49, 240 mg QD on Day 50-56, 260 mg QD on Day 57-63 of Period 6."},{"id":"OG006","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."},{"id":"OG007","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."},{"id":"OG008","title":"Cohort 1: Midazolam 2 mg (Period 9)","description":"Participants in Cohort 1 received SD of midazolam 2 mg on Day 1 of Period 9."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"16"},{"groupId":"OG003","value":"16"},{"groupId":"OG004","value":"16"},{"groupId":"OG005","value":"16"},{"groupId":"OG006","value":"8"},{"groupId":"OG007","value":"7"},{"groupId":"OG008","value":"8"}]}],"classes":[{"title":"Number of participants with all-causality TEAEs","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"14"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"6"},{"groupId":"OG005","value":"15"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"2"}]}]},{"title":"Number of participants with all-causality SAEs","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}]},{"title":"Number of participants with treatment-related TEAEs","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"14"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"15"},{"groupId":"OG006","value":"1"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"2"}]}]},{"title":"Number of participants with treatment-related SAEs","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)","description":"Laboratory tests (including hematology, clinical chemistry, urinalysis) were reported and abnormalities were defined for laboratory values that met specific criteria.","populationDescription":"All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From first dose (Day 1) to follow-up telephone contact (Days 153 to 160) in Cohort 1","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"OG002","title":"Cohort 1: PF-07081532 Titration up to 80 mg QD (Period 3)","description":"Participants in Cohort 1 received PF-07081532 20 mg once daily (QD) on Day 1-7, 40 mg QD on Day 8-14, 60 mg QD on Day 15-21, 80 mg QD on Day 22-28 of Period 3."},{"id":"OG003","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG004","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"OG005","title":"Cohort 1: PF-07081532 Titration up to 260 mg QD (Period 6)","description":"Participants in Cohort 1 received PF-07081532 100 mg QD on Day 1-7, 120 mg QD on DAY 8-14, 140 mg QD on Day 15-21, 160 mg QD on Day 22-28, 180 mg QD on Day 29-35, 200 mg QD on Day 36-42, 220 mg QD on Day 43-49, 240 mg QD on Day 50-56, 260 mg QD on Day 57-63 of Period 6."},{"id":"OG006","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."},{"id":"OG007","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."},{"id":"OG008","title":"Cohort 1: Midazolam 2 mg (Period 9)","description":"Participants in Cohort 1 received SD of midazolam 2 mg on Day 1 of Period 9."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"16"},{"groupId":"OG003","value":"16"},{"groupId":"OG004","value":"16"},{"groupId":"OG005","value":"16"},{"groupId":"OG006","value":"8"},{"groupId":"OG007","value":"7"},{"groupId":"OG008","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"14"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"6"},{"groupId":"OG008","value":"7"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Percentage of Change From Baseline in Body Weight by Period 9 Day 1","description":"Percentage of changes from Baseline in body weight of the participants were measured.","populationDescription":"All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Percentage Change","timeFrame":"From baseline (last pre-dose measurement in Period 1) to Period 9 Day 1 (Day 124)","groups":[{"id":"OG000","title":"All Participants","description":"Participants underwent Period 1 to 9 and received study interventions as follows: SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1; SD of LE 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2; PF-07081532 titrated to 80 mg QD on Day 1-28 of Period 3; PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4; PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5; PF-07081532 titrated to 260 mg QD on Day 1-63 of Period 6; PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7; PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8; SD of midazolam 2 mg on Day 1 of Period 9."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.55","lowerLimit":"-13.0","upperLimit":"-7.1"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Number of Participants With Completed Suicide, Suicide Attempt, Preparatory Acts Towards Imminent Suicidal Behavior, Suicidal Ideation, or Self-Injurious Behavior of No Suicidal Intent As Assessed on the C-SSRS","description":"The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS items were mapped to the following categories: completed suicide, suicide attempt, preparatory acts towards imminent suicidal behavior, suicidal ideation, and self-injurious behavior of no suicidal intent. Number of participants with completed suicide, suicide attempt, preparatory acts towards imminent suicidal behavior, suicidal ideation, or self-injurious behavior of no suicidal intent as assessed on the C-SSRS are reported below.","populationDescription":"All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable C-SSRS results were analyzed.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Screening, Study Day -1 (D-1) (ie, Period 1 Day -1 [P1D-1]), D7 (P3D1), D21 (P3D15), D35 (P4D1), D54 (P6D14), D68 (P6D28), D82 (P6D42), D96 (P6D56), D103 (P6D63), D110 (P8D6) and at follow up visit D132-135","groups":[{"id":"OG000","title":"All Participants","description":"Participants underwent Period 1 to 9 and received study interventions as follows: SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1; SD of LE 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2; PF-07081532 titrated to 80 mg QD on Day 1-28 of Period 3; PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4; PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5; PF-07081532 titrated to 260 mg QD on Day 1-63 of Period 6; PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7; PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8; SD of midazolam 2 mg on Day 1 of Period 9."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Patient Health Quessionare-9 (PHQ-9) Total Scores","description":"The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The PHQ-9 is completed by participants and reviewed by site staff at the pre-defined time points. The total score is derived by adding the corresponding values of responses to each item. The total score ranges from 0 to 27, with the following interpretation: 1-4: Minimal depression; 5-9: Mild depression; 10-14: Moderate depression; 15-19: Moderately severe depression; 20-27: Severe depression.","populationDescription":"All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable PHQ-9 results were analyzed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score","timeFrame":"Screening, Study Day -1 (D-1) (ie, Period 1 Day -1 [P1D-1]), D7 (P3D1), D21 (P3D15), D35 (P4D1), D54 (P6D14), D68 (P6D28), D82 (P6D42), D96 (P6D56), D103 (P6D63), D110 (P8D6) and at follow up visit D132-135","groups":[{"id":"OG000","title":"All Participants","description":"Participants underwent Period 1 to 9 and received study interventions as follows: SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1; SD of LE 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2; PF-07081532 titrated to 80 mg QD on Day 1-28 of Period 3; PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4; PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5; PF-07081532 titrated to 260 mg QD on Day 1-63 of Period 6; PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7; PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8; SD of midazolam 2 mg on Day 1 of Period 9."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"classes":[{"title":"Screening","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.3","spread":"0.79"}]}]},{"title":"Period 1 Day -1 / Midazolam 2 mg + Omeprazole 20 mg","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.34"}]}]},{"title":"Period 3 Day 1 / PF-07081532 titration up to 80 mg QD","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.25"}]}]},{"title":"Period 3 Day 15 / PF-07081532 titration up to 80 mg QD","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.1","spread":"2.42"}]}]},{"title":"Period 4 Day 1 / PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.0","spread":"2.63"}]}]},{"title":"Period 6 Day 14 / PF-07081532 titration up to 260 mg QD","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.6","spread":"4.32"}]}]},{"title":"Period 6 Day 28 / PF-07081532 titration up to 260 mg QD","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.6","spread":"1.12"}]}]},{"title":"Period 6 Day 42 / PF-07081532 titration up to 260 mg QD","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"1.63"}]}]},{"title":"Period 6 Day 56 / PF-07081532 titration up to 260 mg QD","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"1.1","spread":"1.92"}]}]},{"title":"Period 6 Day 63 / PF-07081532 titration up to 260 mg QD","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.9","spread":"1.64"}]}]},{"title":"Period 8 Day 6 / PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"1.39"}]}]},{"title":"Follow Up","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.26"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: AUCinf of Midazolam in Period 9","description":"Midazolam was given on Day 1 in Period 9 of Cohort 1 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng*hr/mL","timeFrame":"For Cohort 1 Period 9: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg (Period 9)","description":"Participants in Cohort 1 received SD of midazolam 2 mg on Day 1 of Period 9."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"39.80","spread":"35"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Maximum Observed Concentration (Cmax) of Midazolam in Period 1, 4, 7","description":"Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/mL","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.613","spread":"38"},{"groupId":"OG001","value":"6.705","spread":"47"},{"groupId":"OG002","value":"6.804","spread":"50"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Time for Cmax (Tmax) of Midazolam in Period 1, 4, 7","description":"Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. Tmax was defined as time for Cmax and was observed directly from data.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"hour","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.50","lowerLimit":"0.500","upperLimit":"3.00"},{"groupId":"OG001","value":"0.500","lowerLimit":"0.500","upperLimit":"2.00"},{"groupId":"OG002","value":"0.767","lowerLimit":"0.500","upperLimit":"2.00"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Apparent Clearance (CL/F) of Midazolam in Period 1, 4, 7","description":"Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. CL/F was defined as apparent clearance and was calculated as dose/AUCinf.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"L/hr","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"50.94","spread":"33"},{"groupId":"OG001","value":"60.08","spread":"38"},{"groupId":"OG002","value":"70.91","spread":"49"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Apparent Volume of Distribution (Vz/F) of Midazolam in Period 1, 4, 7","description":"Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf\\*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Liter (L)","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"544.9","spread":"30"},{"groupId":"OG001","value":"605.3","spread":"28"},{"groupId":"OG002","value":"664.5","spread":"32"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Terminal Half-Life (t1/2) of Midazolam in Period 1, 4, 7","description":"Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. t1/2 was defined as terminal half life and was calculated as loge(2)/kel.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hour","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.539","spread":"1.4445"},{"groupId":"OG001","value":"7.078","spread":"1.2904"},{"groupId":"OG002","value":"6.659","spread":"1.5587"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Cmax of Omeprazole in Period 1, 4, 7","description":"Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","populationDescription":"Participants who received at least 1 dose of omeprazole, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/mL","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"266.4","spread":"112"},{"groupId":"OG001","value":"88.42","spread":"271"},{"groupId":"OG002","value":"169.9","spread":"209"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Tmax of Omeprazole in Period 1, 4, 7","description":"Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. Tmax was defined as time for Cmax and was observed directly from data.","populationDescription":"Participants who received at least 1 dose of omeprazole, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"hour","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5.99","lowerLimit":"2.00","upperLimit":"14.3"},{"groupId":"OG001","value":"8.33","lowerLimit":"4.00","upperLimit":"23.4"},{"groupId":"OG002","value":"11.1","lowerLimit":"6.00","upperLimit":"23.4"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: CL/F of Omeprazole in Period 1, 4, 7","description":"Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. CL/F was defined as apparent clearance and was calculated as dose/AUCinf.","populationDescription":"Participants who received at least 1 dose of omeprazole, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"L/hr","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"17.19","spread":"92"},{"groupId":"OG001","value":"21.43","spread":"198"},{"groupId":"OG002","value":"17.26","spread":"118"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Vz/F of Omeprazole in Period 1, 4, 7","description":"Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf\\*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.","populationDescription":"Participants who received at least 1 dose of omeprazole, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"L","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"41.26","spread":"69"},{"groupId":"OG001","value":"49.81","spread":"150"},{"groupId":"OG002","value":"44.48","spread":"109"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: t1/2 of Omeprazole in Period 1, 4, 7","description":"Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole PK at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf ×kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.","populationDescription":"Participants who received at least 1 dose of omeprazole, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hour","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.793","spread":"0.77789"},{"groupId":"OG001","value":"1.705","spread":"0.65741"},{"groupId":"OG002","value":"1.800","spread":"0.28355"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Cmax of LE in Period 2, 5, 8","description":"LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","populationDescription":"Participants who received at least 1 dose of LE, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"pg/mL","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1919","spread":"45"},{"groupId":"OG001","value":"1532","spread":"41"},{"groupId":"OG002","value":"1684","spread":"82"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Tmax of LE in Period 2, 5, 8","description":"LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","populationDescription":"Participants who received at least 1 dose of LE, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"hour","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.00","lowerLimit":"0.750","upperLimit":"4.00"},{"groupId":"OG001","value":"3.02","lowerLimit":"0.750","upperLimit":"12.0"},{"groupId":"OG002","value":"4.10","lowerLimit":"0.750","upperLimit":"23.5"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: CL/F of LE in Period 2, 5, 8","description":"LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","populationDescription":"Participants who received at least 1 dose of LE, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"L/hr","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.043","spread":"51"},{"groupId":"OG001","value":"3.887","spread":"52"},{"groupId":"OG002","value":"2.265","spread":"54"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Vz/F of LE in Period 2, 5, 8","description":"LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf\\*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.","populationDescription":"Participants who received at least 1 dose of LE, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"L","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"380.0","spread":"44"},{"groupId":"OG001","value":"251.7","spread":"45"},{"groupId":"OG002","value":"133.6","spread":"55"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: t1/2 of LE in Period 2, 5, 8","description":"LE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for LE PK at the preset time points described in the Time Frame. t1/2 was defined as terminal half life and was calculated as loge(2)/kel.","populationDescription":"Participants who received at least 1 dose of LE, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hour","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to LE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"5"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"44.33","spread":"8.7994"},{"groupId":"OG001","value":"45.25","spread":"5.9429"},{"groupId":"OG002","value":"41.26","spread":"5.7709"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Cmax of EE in Period 2, 5, 8","description":"EE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for EE PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","populationDescription":"Participants who received at least 1 dose of EE, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"pg/mL","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to EE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"42.44","spread":"33"},{"groupId":"OG001","value":"37.82","spread":"35"},{"groupId":"OG002","value":"34.03","spread":"30"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Tmax of EE in Period 2, 5, 8","description":"EE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for EE PK at the preset time points described in the Time Frame. Tmax was defined as time for Cmax and was observed directly from data.","populationDescription":"Participants who received at least 1 dose of EE, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"hour","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to EE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.00","lowerLimit":"0.750","upperLimit":"4.00"},{"groupId":"OG001","value":"2.00","lowerLimit":"0.750","upperLimit":"8.00"},{"groupId":"OG002","value":"2.00","lowerLimit":"0.750","upperLimit":"4.20"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: CL/F of EE in Period 2, 5, 8","description":"EE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for EE PK at the preset time points described in the Time Frame. CL/F was defined as apparent clearance and was calculated as dose/AUCinf.","populationDescription":"Participants who received at least 1 dose of EE, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"L/hr","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to EE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"238.6","spread":"37"},{"groupId":"OG001","value":"235.3","spread":"26"},{"groupId":"OG002","value":"256.9","spread":"29"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Vz/F of EE in Period 2, 5, 8","description":"EE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for EE PK at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf\\*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.","populationDescription":"Participants who received at least 1 dose of EE, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"L","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to EE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7565","spread":"32"},{"groupId":"OG001","value":"8517","spread":"34"},{"groupId":"OG002","value":"7998","spread":"25"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: t1/2 of EE in Period 2, 5, 8","description":"EE was given on Day 1 in Period 2, 5, 8 of Cohort 1 and blood samples were collected for EE PK at the preset time points described in the Time Frame. t1/2 was defined as terminal half life and was calculated as loge(2)/kel.","populationDescription":"Participants who received at least 1 dose of EE, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hour","timeFrame":"For Cohort 1 Periods 2, 5, and 8: At 0 (prior to EE dose), 0.75, 2, 4, 8, 12, 24, 48, 72, 96 and 120 hours post LE dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + LE 0.15 mg & EE 0.03 mg (Period 8)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22.42","spread":"4.5451"},{"groupId":"OG001","value":"25.54","spread":"4.8147"},{"groupId":"OG002","value":"22.03","spread":"4.5676"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Metabolite/Parent Ratio for AUCinf (MRAUCinf) of 1-Hydroxy Midazolam in Period 1, 4, 7","description":"Midazolam was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for midazolam (parent) and and its metabolite 1-Hydroxy Midazolam PK at the preset time points described in the Time Frame. MRAUCinf was calculated as (AUCinf, metabolite/AUCinf, parent) \\* (MWparent/MWmetabolite). MW = molecular weight.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.3143","spread":"24"},{"groupId":"OG001","value":"0.4480","spread":"39"},{"groupId":"OG002","value":"0.4314","spread":"49"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: MRAUCinf of 5-Hydroxy Omeprazole in Period 1, 4, 7","description":"Omeprazole was given on Day 1 in Period 1, 4, 7 of Cohort 1 and blood samples were collected for omeprazole (parent) and and its metabolite 5-Hydroxy omeprazole PK at the preset time points described in the Time Frame. MRAUCinf was calculated as (AUCinf, metabolite/AUCinf, parent) \\* (MWparent/MWmetabolite). MW = molecular weight.","populationDescription":"Participants who received at least 1 dose of omeprazole, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"For Cohort 1 Periods 1, 4, and 7: At 0 (prior to omeprazole dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4."},{"id":"OG002","title":"Cohort 1: PF-07081532 260 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 7)","description":"Participants in Cohort 1 received PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"3"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.3752","spread":"93"},{"groupId":"OG001","value":"0.4060","spread":"136"},{"groupId":"OG002","value":"0.3790","spread":"39"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Area Under the Plasma Concentration-Time Profile From Time 0 to 24 Hours (AUC24) of PF-07081532 in Period 3 and 6","description":"PF-07081532 was given titrated to 80 mg QD on Day 1-28 of Period 3, and titrated to 260 mg QD on Day 1-63 of Period 6 in Cohort 1, and blood samples were collected for PF-07081532 PK at the preset time points described in the Time Frame. AUC24 was defined as area under the plasma concentration-time profile from time 0 to 24 hours and was determined using the linear/log trapezoidal method.","populationDescription":"Participants who received at least 1 dose of PF-07081532, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng*hr/mL","timeFrame":"For Cohort 1 Periods 3 and 6: At 0 , 0.5, 1, 2, 4, 6, 8, 10, 14, and 24 hours post PF-07081532 dose on Day 28 of Period 3 and Day 63 of Period 6","groups":[{"id":"OG000","title":"Cohort 1: PF-07081532 Titration up to 80 mg QD (Period 3)","description":"Participants in Cohort 1 received PF-07081532 20 mg once daily (QD) on Day 1-7, 40 mg QD on Day 8-14, 60 mg QD on Day 15-21, 80 mg QD on Day 22-28 of Period 3."},{"id":"OG001","title":"Cohort 1: PF-07081532 Titration up to 260 mg QD (Period 6)","description":"Participants in Cohort 1 received PF-07081532 100 mg QD on Day 1-7, 120 mg QD on DAY 8-14, 140 mg QD on Day 15-21, 160 mg QD on Day 22-28, 180 mg QD on Day 29-35, 200 mg QD on Day 36-42, 220 mg QD on Day 43-49, 240 mg QD on Day 50-56, 260 mg QD on Day 57-63 of Period 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"250200","spread":"31"},{"groupId":"OG001","value":"1239000","spread":"49"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Cmax of PF-07081532 in Period 3 and 6","description":"PF-07081532 was given titrated to 80 mg QD on Day 1-28 of Period 3, and titrated to 260 mg QD on Day 1-63 of Period 6 in Cohort 1, and blood samples were collected for PF-07081532 PK at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","populationDescription":"Participants who received at least 1 dose of PF-07081532, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/mL","timeFrame":"For Cohort 1 Periods 3 and 6: At 0 , 0.5, 1, 2, 4, 6, 8, 10, 14, and 24 hours post PF-07081532 dose on Day 28 of Period 3 and Day 63 of Period 6","groups":[{"id":"OG000","title":"Cohort 1: PF-07081532 Titration up to 80 mg QD (Period 3)","description":"Participants in Cohort 1 received PF-07081532 20 mg once daily (QD) on Day 1-7, 40 mg QD on Day 8-14, 60 mg QD on Day 15-21, 80 mg QD on Day 22-28 of Period 3."},{"id":"OG001","title":"Cohort 1: PF-07081532 Titration up to 260 mg QD (Period 6)","description":"Participants in Cohort 1 received PF-07081532 100 mg QD on Day 1-7, 120 mg QD on DAY 8-14, 140 mg QD on Day 15-21, 160 mg QD on Day 22-28, 180 mg QD on Day 29-35, 200 mg QD on Day 36-42, 220 mg QD on Day 43-49, 240 mg QD on Day 50-56, 260 mg QD on Day 57-63 of Period 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15820","spread":"29"},{"groupId":"OG001","value":"70710","spread":"40"}]}]}]},{"type":"SECONDARY","title":"Cohort 1: Tmax of PF-07081532 in Period 3 and 6","description":"PF-07081532 was given titrated to 80 mg QD on Day 1-28 of Period 3, and titrated to 260 mg QD on Day 1-63 of Period 6 in Cohort 1, and blood samples were collected for PF-07081532 PK at the preset time points described in the Time Frame. Tmax was defined as time for Cmax and was observed directly from data.","populationDescription":"Participants who received at least 1 dose of PF-07081532, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"hour","timeFrame":"For Cohort 1 Periods 3 and 6: At 0 , 0.5, 1, 2, 4, 6, 8, 10, 14, and 24 hours post PF-07081532 dose on Day 28 of Period 3 and Day 63 of Period 6","groups":[{"id":"OG000","title":"Cohort 1: PF-07081532 Titration up to 80 mg QD (Period 3)","description":"Participants in Cohort 1 received PF-07081532 20 mg once daily (QD) on Day 1-7, 40 mg QD on Day 8-14, 60 mg QD on Day 15-21, 80 mg QD on Day 22-28 of Period 3."},{"id":"OG001","title":"Cohort 1: PF-07081532 Titration up to 260 mg QD (Period 6)","description":"Participants in Cohort 1 received PF-07081532 100 mg QD on Day 1-7, 120 mg QD on DAY 8-14, 140 mg QD on Day 15-21, 160 mg QD on Day 22-28, 180 mg QD on Day 29-35, 200 mg QD on Day 36-42, 220 mg QD on Day 43-49, 240 mg QD on Day 50-56, 260 mg QD on Day 57-63 of Period 6."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.00","lowerLimit":"2.00","upperLimit":"14.0"},{"groupId":"OG001","value":"6.00","lowerLimit":"4.00","upperLimit":"10.0"}]}]}]},{"type":"SECONDARY","title":"Cohort 2: Number of Participants With All-Causality and Treatment-Related TEAEs","description":"An adverse event (AE) was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Relatedness to study treatment was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were events between first dose of study treatment and up to approximately 35 days that were absent before treatment or that worsened relative to pretreatment state.","populationDescription":"All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From first dose (Day 1) to follow-up telephone contact (Days 193 to 200) in Cohort 2","groups":[{"id":"OG000","title":"Cohort 2: Midazolam 2 mg (Period 1)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 2: Semaglutide Titration up to 2.4 mg QW (Period 2)","description":"Participants in Cohort 2 received semaglutide 0.25 mg once weekly (QW) on Week 1-4, 0.5 mg QW on Week 5-8, 1.0 mg QW on Week 9-12, 1.7 mg QW on Week 13-16, 2.4 mg QW on Week 17-21 of Period 2."},{"id":"OG002","title":"Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3)","description":"Participants in Cohort 2 received semaglutide 2.4 mg QW and SD of midazolam 2 mg on Day 1 of Period 3."},{"id":"OG003","title":"Cohort 2: Midazolam 2 mg (Period 4)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 4."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"10"}]}],"classes":[{"title":"Number of participants with all-causality TEAEs","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"3"}]}]},{"title":"Number of participants with all-causality SAEs","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Number of participants with treatment-related TEAEs","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"1"}]}]},{"title":"Number of participants with treatment-related SAEs","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Cohort 2: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)","description":"Laboratory tests (including hematology, clinical chemistry, urinalysis) were reported and abnormalities were defined for laboratory values that met specific criteria.","populationDescription":"All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"From first dose (Day 1) to follow-up telephone contact (Days 193 to 200) in Cohort 2","groups":[{"id":"OG000","title":"Cohort 2: Midazolam 2 mg (Period 1)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 2: Semaglutide Titration up to 2.4 mg QW (Period 2)","description":"Participants in Cohort 2 received semaglutide 0.25 mg once weekly (QW) on Week 1-4, 0.5 mg QW on Week 5-8, 1.0 mg QW on Week 9-12, 1.7 mg QW on Week 13-16, 2.4 mg QW on Week 17-21 of Period 2."},{"id":"OG002","title":"Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3)","description":"Participants in Cohort 2 received semaglutide 2.4 mg QW and SD of midazolam 2 mg on Day 1 of Period 3."},{"id":"OG003","title":"Cohort 2: Midazolam 2 mg (Period 4)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 4."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"8"}]}]}]},{"type":"SECONDARY","title":"Cohort 2: Percentage of Change From Baseline in Body Weight by Period 4 Day 1","description":"Percentage of changes from Baseline in body weight of the participants were measured.","populationDescription":"All participants randomly assigned to study intervention and who took at least 1 dose of study intervention.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Percentage Change","timeFrame":"From baseline (last pre-dose measurement in Period 1) to Period 4 Day 1 (Day 165)","groups":[{"id":"OG000","title":"All Participants","description":"Participants underwent Period 1 to 4 and received study interventions as follows: SD of midazolam 2 mg on Day 1 of Period 1; Semaglutide titrated to 2.4 mg QW on Week 1-21 of Period 2; Semaglutide 2.4 mg QW and SD of midazolam 2 mg on Day 1 of Period 3; SD of midazolam 2 mg on Day 1 of Period 4."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.15","lowerLimit":"-22.0","upperLimit":"-5.9"}]}]}]},{"type":"SECONDARY","title":"Cohort 2: Number of Participants With Completed Suicide, Suicide Attempt, Preparatory Acts Towards Imminent Suicidal Behavior, Suicidal Ideation, or Self-Injurious Behavior of No Suicidal Intent As Assessed on the C-SSRS","description":"The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS items were mapped to the following categories: completed suicide, suicide attempt, preparatory acts towards imminent suicidal behavior, suicidal ideation, and self-injurious behavior of no suicidal intent. Number of participants with completed suicide, suicide attempt, preparatory acts towards imminent suicidal behavior, suicidal ideation, or self-injurious behavior of no suicidal intent as assessed on the C-SSRS are reported below.","populationDescription":"All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable C-SSRS results were analyzed.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Screening, D-1 (P1D-1), P2 Week 5 [W5], P2W9, P2W13, P2W17, D150 (P3D2), at follow up visit (Day 172-175)","groups":[{"id":"OG000","title":"All Participants","description":"Participants underwent Period 1 to 4 and received study interventions as follows: SD of midazolam 2 mg on Day 1 of Period 1; Semaglutide titrated to 2.4 mg QW on Week 1-21 of Period 2; Semaglutide 2.4 mg QW and SD of midazolam 2 mg on Day 1 of Period 3; SD of midazolam 2 mg on Day 1 of Period 4."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Cohort 2: PHQ-9 Total Scores","description":"The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The PHQ-9 is completed by participants and reviewed by site staff at the pre-defined time points. The total score is derived by adding the corresponding values of responses to each item. The total score ranges from 0 to 27, with the following interpretation: 1-4: Minimal depression; 5-9: Mild depression; 10-14: Moderate depression; 15-19: Moderately severe depression; 20-27: Severe depression.","populationDescription":"All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable PHQ-9 results were analyzed.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score","timeFrame":"Screening, D-1 (P1D-1), P2 Week 5 [W5], P2W9, P2W13, P2W17, D150 (P3D2), at follow up visit (Day 172-175)","groups":[{"id":"OG000","title":"All Participants","description":"Participants underwent Period 1 to 9 and received study interventions as follows: SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1; SD of LE 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2; PF-07081532 titrated to 80 mg QD on Day 1-28 of Period 3; PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4; PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5; PF-07081532 titrated to 260 mg QD on Day 1-63 of Period 6; PF-07081532 260 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 7; PF-07081532 260 mg QD on Day 1-5 of Period 8, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 8; SD of midazolam 2 mg on Day 1 of Period 9.\n\n1\\."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"classes":[{"title":"Screening","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.25"}]}]},{"title":"Period 1 Day -1 / Midazolam 2 mg","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"0.40"}]}]},{"title":"Period 2 Week 5 / Semaglutide titration up to 2.4 mg QW","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.3","spread":"0.46"}]}]},{"title":"Period 2 Week 9 / Semaglutide titration up to 2.4 mg QW","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.1","spread":"0.35"}]}]},{"title":"Period 2 Week 13 / Semaglutide titration up to 2.4 mg QW","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"0.43"}]}]},{"title":"Period 2 Week 17 / Semaglutide titration up to 2.4 mg QW","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.2","spread":"0.43"}]}]},{"title":"Period 3 Day 2 / Semaglutide 2.4 mg QW + Midazolam 2 mg","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"1.33"}]}]},{"title":"Follow Up","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"14"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"0.0","spread":"0.00"}]}]}]},{"type":"SECONDARY","title":"Cohort 2: AUCinf of Midazolam in Period 4","description":"Midazolam was given on Day 1 in Period 4 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng*hr/mL","timeFrame":"For Cohort 2 Period 4: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14 and 24 hours post midazolam dose on Day 1","groups":[{"id":"OG000","title":"Cohort 2: Midazolam 2 mg (Period 4)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 4."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33.67","spread":"38"}]}]}]},{"type":"SECONDARY","title":"Cohort 2: Cmax of Midazolam in Period 1 and 3","description":"Midazolam was given on Day 1 in Period 1 and 3 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. Cmax was defined as maximum observed concentration and was observed directly from data.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"ng/mL","timeFrame":"For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 2: Midazolam 2 mg (Period 1)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3)","description":"Participants in Cohort 2 received semaglutide 2.4 mg QW and SD of midazolam 2 mg on Day 1 of Period 3."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6.234","spread":"32"},{"groupId":"OG001","value":"6.483","spread":"40"}]}]}]},{"type":"SECONDARY","title":"Cohort 2: Tmax of Midazolam in Period 1 and 3","description":"Midazolam was given on Day 1 in Period 1 and 3 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. Tmax was defined as time for Cmax and was observed directly from data.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"hour","timeFrame":"For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 2: Midazolam 2 mg (Period 1)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3)","description":"Participants in Cohort 2 received semaglutide 2.4 mg QW and SD of midazolam 2 mg on Day 1 of Period 3."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00","lowerLimit":"0.500","upperLimit":"2.08"},{"groupId":"OG001","value":"1.00","lowerLimit":"0.500","upperLimit":"4.00"}]}]}]},{"type":"SECONDARY","title":"Cohort 2: CL/F of Midazolam in Period 1 and 3","description":"Midazolam was given on Day 1 in Period 1 and 3 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. CL/F was defined as apparent clearance and was calculated as dose/AUCinf.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"L/hr","timeFrame":"For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 2: Midazolam 2 mg (Period 1)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3)","description":"Participants in Cohort 2 received semaglutide 2.4 mg QW and SD of midazolam 2 mg on Day 1 of Period 3."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"58.07","spread":"43"},{"groupId":"OG001","value":"57.80","spread":"48"}]}]}]},{"type":"SECONDARY","title":"Cohort 2: Vz/F of Midazolam in Period 1 and 3","description":"Midazolam was given on Day 1 in Period 1 and 3 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. Vz/F was defined as apparent volume of distribution and was calculated as dose/(AUCinf\\*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"L","timeFrame":"For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 2: Midazolam 2 mg (Period 1)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3)","description":"Participants in Cohort 2 received semaglutide 2.4 mg QW and SD of midazolam 2 mg on Day 1 of Period 3."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"618.2","spread":"37"},{"groupId":"OG001","value":"516.5","spread":"37"}]}]}]},{"type":"SECONDARY","title":"Cohort 2: t1/2 of Midazolam in Period 1 and 3","description":"Midazolam was given on Day 1 in Period 1 and 3 of Cohort 2 and blood samples were collected for midazolam pharmacokinetic (PK) at the preset time points described in the Time Frame. t1/2 was defined as terminal half life and was calculated as loge(2)/kel.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hour","timeFrame":"For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 2: Midazolam 2 mg (Period 1)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3)","description":"Participants in Cohort 2 received semaglutide 2.4 mg QW and SD of midazolam 2 mg on Day 1 of Period 3."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.527","spread":"1.6147"},{"groupId":"OG001","value":"6.347","spread":"1.4305"}]}]}]},{"type":"SECONDARY","title":"Cohort 2: MRAUCinf of 1-Hydroxy Midazolam in Period 1, 3, 4","description":"Midazolam was given on Day 1 in Period 1, 3, 4 of Cohort 2 and blood samples were collected for midazolam (parent) and and its metabolite 1-Hydroxy Midazolam PK at the preset time points described in the Time Frame. MRAUCinf was calculated as (AUCinf, metabolite/AUCinf, parent) \\* (MWparent/MWmetabolite). MW = molecular weight.","populationDescription":"Participants who received at least 1 dose of midazolam, and had at least 1 of the PK parameters of interest calculated were included in the analysis.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"For Cohort 2 Periods 1 and 3: At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24 hours post midazolam dose on Day 1 of each period","groups":[{"id":"OG000","title":"Cohort 2: Midazolam 2 mg (Period 1)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 1."},{"id":"OG001","title":"Cohort 2: Semaglutide 2.4 mg QW + Midazolam 2 mg (Period 3)","description":"Participants in Cohort 2 received semaglutide 2.4 mg QW and SD of midazolam 2 mg on Day 1 of Period 3."},{"id":"OG002","title":"Cohort 2: Midazolam 2 mg (Period 4)","description":"Participants in Cohort 2 received SD of midazolam 2 mg on Day 1 of Period 4."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.3262","spread":"42"},{"groupId":"OG001","value":"0.3818","spread":"52"},{"groupId":"OG002","value":"0.3221","spread":"35"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From first dose (Day 1) to follow-up telephone contact (Days 153 to 160) in Cohort 1 and from first dose (Day 1) to follow-up telephone contact (Days 193 to 200) in Cohort 2.","eventGroups":[{"id":"EG000","title":"Cohort 1: Midazolam 2 mg + Omeprazole 20 mg (Period 1)","description":"Participants in Cohort 1 received single dose (SD) of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 1.","deathsNumAffected":0,"deathsNumAtRisk":16,"seriousNumAffected":0,"seriousNumAtRisk":16,"otherNumAffected":1,"otherNumAtRisk":16},{"id":"EG001","title":"Cohort 1: LE 0.15 mg & EE 0.03 mg (Period 2)","description":"Participants in Cohort 1 received SD of levonorgestrel (LE) 0.15 mg and ethinyl estradiol (EE) 0.03 mg on Day 1 of Period 2.","deathsNumAffected":0,"deathsNumAtRisk":16,"seriousNumAffected":0,"seriousNumAtRisk":16,"otherNumAffected":2,"otherNumAtRisk":16},{"id":"EG002","title":"Cohort 1: PF-07081532 Titration up to 80 mg QD (Period 3)","description":"Participants in Cohort 1 received PF-07081532 20 mg once daily (QD) on Day 1-7, 40 mg QD on Day 8-14, 60 mg QD on Day 15-21, 80 mg QD on Day 22-28 of Period 3.","deathsNumAffected":0,"deathsNumAtRisk":16,"seriousNumAffected":0,"seriousNumAtRisk":16,"otherNumAffected":14,"otherNumAtRisk":16},{"id":"EG003","title":"Cohort 1: PF-07081532 80 mg QD + Midazolam 2 mg + Omeprazole 20 mg (Period 4)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD, SD of midazolam 2 mg and omeprazole 20 mg on Day 1 of Period 4.","deathsNumAffected":0,"deathsNumAtRisk":16,"seriousNumAffected":0,"seriousNumAtRisk":16,"otherNumAffected":2,"otherNumAtRisk":16},{"id":"EG004","title":"Cohort 1: PF-07081532 80 mg QD + LE 0.15 mg & EE 0.03 mg (Period 5)","description":"Participants in Cohort 1 received PF-07081532 80 mg QD on Day 1-5 of Period 5, and SD of LE 0.15 mg and EE 0.03 mg on Day 1 of Period 5.","deathsNumAffected":0,"deathsNumAtRisk":16,"seriousNumAffected":0,"seriousNumAtRisk":16,"otherNumAffected":6,"otherNumAtRisk":16},{"id":"EG005","title":"Cohort 1: PF-07081532 Titration up to 260 mg QD (Period 6)","description":"Participants in Cohort 1 received PF-07081532 100 mg QD on Day 1-7, 120 mg QD on DAY 8-14, 140 mg QD on Day 15-21, 160 mg QD on Day 22-28, 180 mg QD on Day 29-35, 200 mg QD on Day 36-42, 220 mg QD on Day 43-49, 240 mg QD on Day 50-56, 260 mg QD on Day 57-63 of Period 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