{"protocolSection":{"identificationModule":{"nctId":"NCT04604496","orgStudyIdInfo":{"id":"C3421014"},"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VARYING DEGREES OF HEPATIC IMPAIREMENT","officialTitle":"A Phase 1, Non-randomized, Open-label, Single-dose, Parallel Cohort Study to Compare the Pharmacokinetics of PF-06882961 in Adult Participants With Varying Degrees of Hepatic Impairment Relative to Participants Without Hepatic Impairment."},"statusModule":{"statusVerifiedDate":"2023-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2020-12-30","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2022-01-10","type":"ACTUAL"},"completionDateStruct":{"date":"2022-01-10","type":"ACTUAL"},"studyFirstSubmitDate":"2020-10-21","studyFirstSubmitQcDate":"2020-10-21","studyFirstPostDateStruct":{"date":"2020-10-27","type":"ACTUAL"},"resultsFirstSubmitDate":"2022-10-24","resultsFirstSubmitQcDate":"2023-09-20","resultsFirstPostDateStruct":{"date":"2024-03-21","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-09-20","lastUpdatePostDateStruct":{"date":"2024-03-21","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of PF-06882961"},"conditionsModule":{"conditions":["Hepatic Impairment","Healthy Volunteers"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"SINGLE","whoMasked":["PARTICIPANT"]}},"enrollmentInfo":{"count":24,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"PF-06882961 participants without Hepatic Impairment","type":"EXPERIMENTAL","description":"This arm includes participants who will receive an oral dose of PF-06882961 20 milligrams (mg) on Day 1","interventionNames":["Drug: PF-06882961 20MG"]},{"label":"PF-06882961 participants with mild Hepatic Impairment","type":"EXPERIMENTAL","description":"This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1","interventionNames":["Drug: PF-06882961 20MG"]},{"label":"PF-06882961 participants with moderate Hepatic Impairment","type":"EXPERIMENTAL","description":"This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1","interventionNames":["Drug: PF-06882961 20MG"]},{"label":"PF-06882961 participants with severe Hepatic Impairment","type":"EXPERIMENTAL","description":"This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1","interventionNames":["Drug: PF-06882961 20MG"]}],"interventions":[{"type":"DRUG","name":"PF-06882961 20MG","description":"PF-06882961 in 20 mg oral tablet will be administered on Day 1","armGroupLabels":["PF-06882961 participants with mild Hepatic Impairment","PF-06882961 participants with moderate Hepatic Impairment","PF-06882961 participants with severe Hepatic Impairment","PF-06882961 participants without Hepatic Impairment"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Maximum Plasma Concentration (Cmax)","description":"Maximum observed plasma PF-06882961 concentration.","timeFrame":"Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1."},{"measure":"Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)","description":"Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to infinite time.","timeFrame":"Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1."},{"measure":"Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)","description":"Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration.","timeFrame":"Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1."},{"measure":"Fraction of Unbound Drug in Plasma (fu)","description":"fu = Cu/C (where Cu represents unbound concentration and C represents total concentration).","timeFrame":"Predose (0 hours), and 4 hours post dose on Day 1."}],"secondaryOutcomes":[{"measure":"Number of Participants Reporting Treatment-emergent Adverse Events (AEs)","description":"Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. AEs included SAEs and non-serious AEs. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). Treatment-related TEAEs were any untoward medical occurrence attributed to study treatment. Relatedness to study treatment was determined by the investigator.","timeFrame":"Baseline to Day 30"},{"measure":"Number of Participants With Clinical Laboratory Abnormalities","description":"Protocol-required safety laboratory assessments included: hemoglobin \\<0.8 x lower limit of normal (LLN), hematocrit \\<0.8 x LLN, erythrocytes \\<0.8 x LLN, ery. mean corpuscular volume \\>1.1 x upper limit of normal (ULN), ery. mean corpuscular hemoglobin \\>1.1 x ULN, platelets \\<0.5 x LLN, eosinophils \\>1.2 x ULN, activated partial thromboplastin time \\>1.1 x ULN, prothrombin time \\>1.1 x ULN, prothrombin intl. normalized ratio \\>1.1 x ULN; bilirubin/direct bilirubin/indirect bilirubin \\>1.5 x ULN, aspartate aminotransferase/alanine aminotransferase/gamma glutamyl transferase \\>3.0 x ULN, albumin \\<0.8 x LLN, urate \\>1.2 x ULN, bicarbonate \\>1.1 x ULN, triacylglycerol lipase \\>1.5 x ULN; urine hemoglobin/urine urobilinogen/urine nitrite/urine leukocyte esterase ≥1.","timeFrame":"Baseline to Day 3"},{"measure":"Number of Participants With Categorical Vital Signs Data","description":"Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) \\<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \\<50 mmHg; 3) supine pulse rate \\<40 or \\>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg.","timeFrame":"Baseline to Day 3"},{"measure":"Number of Participants With Categorical Electrocardiogram (ECG) Data","description":"ECG categorical criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (≥) 300 millisecond (msec), b) ≥25% increase when baseline is \\> 200 msec or ≥50% increase when baseline is less than or equal to (≤) 200 msec.\n\n2\\. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline.\n\n3\\. QTcF interval (QT corrected using the Fridericia formula): a) \\>450 msec and ≤480 msec, b) \\>480 msec and ≤500 msec, c) \\>500 msec, d) \\>30 msec and ≤60 msec increase from baseline, e) \\>60 msec increase from baseline","timeFrame":"Baseline to Day 3"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male and female participants between the ages of 18 (or the minimum country-specific age of consent if \\>18) and 70 years, inclusive, at the screening visit:\n* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n* Body mass index (BMI) of 17.5 to 38.0 kg/m2, inclusive; and a total body weight \\>50 kg (110 lb), at the screening visit; with a single repeat assessment of total body weight (and hence BMI), on a separate day permitted to assess eligibility, if needed.\n\nExclusion Criteria:\n\n* Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection); NOTE: Participants who have undergone cholecystectomy and/or appendectomy are eligible for this study as long as the surgery occurred more than 6 months prior to Screening;\n* At screening, participants with a positive result for human immunodeficiency virus (HIV) antibodies, as assessed by sponsor-identified central laboratory, with a single repeat permitted to assess eligibility, if needed;\n* A positive COVID-19 test at screening;\n* A diagnosis of type 2 diabetes mellitus (T2DM) that is documented by medical history;\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator's judgement;\n* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study;\n* Use of prior/concomitant therapies\n* Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer);\n* Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF-06882961;\n* Participants with ANY of the following abnormalities in clinical laboratory tests at Visit 1, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:\n\nHbA1c ≥6.5%; FPG ≥126 mg/Dl; eGFR\\<60 mL/min/1.73m2;\n\n* A positive urine drug test, for illicit drugs at screening, as assessed by sponsor-identified central laboratory. However, participants in Cohorts 2-4, only, who have been medically prescribed opiates/opioids or benzodiazepines and report the use of these drugs to the investigator at the Screening visit will be allowed to participate; NOTE: repeat urine drug testing is not permitted in this study;\n* At screening or Day -1, a positive breath alcohol test, as assessed using kits provided by sponsor-identified central laboratory, with a single repeat on a separate day permitted to assess eligibility, if needed;\n* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing and until the follow-up contact; 13. History of sensitivity to heparin or heparin-induced thrombocytopenia, only if heparin is used to flush intravenous catheters used during serial blood collections;\n* Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol;\n* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"University of Miami Division of Clinical Pharmacology","city":"Miami","state":"Florida","zip":"33136","country":"United States","geoPoint":{"lat":25.77427,"lon":-80.19366}},{"facility":"Orlando Clinical Research Center","city":"Orlando","state":"Florida","zip":"32809","country":"United States","geoPoint":{"lat":28.53834,"lon":-81.37924}}]},"referencesModule":{"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://pmiform.com/clinical-trial-info-request?StudyID=C3421014"}]},"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":"A total of 29 participants were screened in the study, among whom, 24 participants were treated with PF-06882961 (Danuglipron).","groups":[{"id":"FG000","title":"Without Hepatic Impairment","description":"Participants without hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"FG001","title":"Mild Hepatic Impairment","description":"Participants with mild hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"FG002","title":"Moderate Hepatic Impairment","description":"Participants with moderate hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"FG003","title":"Severe Hepatic Impairment","description":"Participants with severe hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."}],"periods":[{"title":"Open Label Treatment","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"6"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"6"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]},{"title":"Follow-Up","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"6"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"6"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The baseline analysis population included all participants enrolled in the study.","groups":[{"id":"BG000","title":"Without Hepatic Impairment","description":"Participants without hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"BG001","title":"Mild Hepatic Impairment","description":"Participants with mild hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"BG002","title":"Moderate Hepatic Impairment","description":"Participants with moderate hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"BG003","title":"Severe Hepatic Impairment","description":"Participants with severe hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"6"},{"groupId":"BG004","value":"24"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"59.3","spread":"3.08"},{"groupId":"BG001","value":"61.7","spread":"5.85"},{"groupId":"BG002","value":"57.7","spread":"7.12"},{"groupId":"BG003","value":"56.2","spread":"10.21"},{"groupId":"BG004","value":"58.7","spread":"6.89"}]}]}]},{"title":"Age, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"45-64 Years","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"18"}]},{"title":">=65 Years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"11"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"13"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"13"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"11"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"White","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"5"},{"groupId":"BG004","value":"22"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Maximum Plasma Concentration (Cmax)","description":"Maximum observed plasma PF-06882961 concentration.","populationDescription":"The analysis population refers to all participants who received at least 1 dose of PF-06882961 and had at least 1 of the pharmacokinetic (PK) parameters of interest calculated.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram per milliliter (ng/mL)","timeFrame":"Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.","groups":[{"id":"OG000","title":"Without Hepatic Impairment","description":"Participants without hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"OG001","title":"Mild Hepatic Impairment","description":"Participants with mild hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"OG002","title":"Moderate Hepatic Impairment","description":"Participants with moderate hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"OG003","title":"Severe Hepatic Impairment","description":"Participants with severe hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23.56","spread":"50"},{"groupId":"OG001","value":"31.37","spread":"33"},{"groupId":"OG002","value":"51.82","spread":"83"},{"groupId":"OG003","value":"78.73","spread":"33"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Test: the mild hepatic impairment group; Reference: the without hepatic impairment group","nonInferiorityType":"OTHER","nonInferiorityComment":"The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.","paramType":"Ratio of adjusted geometric means","paramValue":"133.17","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"81.97","ciUpperLimit":"216.37"},{"groupIds":["OG000","OG002"],"groupDescription":"Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group","nonInferiorityType":"OTHER","nonInferiorityComment":"The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.","paramType":"Ratio of adjusted geometric means","paramValue":"219.98","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"135.39","ciUpperLimit":"357.41"},{"groupIds":["OG000","OG003"],"groupDescription":"Test: the severe hepatic impairment group; Reference: the without hepatic impairment group","nonInferiorityType":"OTHER","nonInferiorityComment":"The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.","paramType":"Ratio of adjusted geometric means","paramValue":"334.21","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"205.70","ciUpperLimit":"543.00"}]},{"type":"PRIMARY","title":"Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)","description":"Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to infinite time.","populationDescription":"The analysis population refers to all participants who received at least 1 dose of PF-06882961 and had at least 1 of the PK parameters of interest calculated.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram*hour per milliliter (ng*hr/mL)","timeFrame":"Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.","groups":[{"id":"OG000","title":"Without Hepatic Impairment","description":"Participants without hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"OG001","title":"Mild Hepatic Impairment","description":"Participants with mild hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"OG002","title":"Moderate Hepatic Impairment","description":"Participants with moderate hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"OG003","title":"Severe Hepatic Impairment","description":"Participants with severe hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"193.4","spread":"83"},{"groupId":"OG001","value":"237.3","spread":"34"},{"groupId":"OG002","value":"546.7","spread":"116"},{"groupId":"OG003","value":"1239","spread":"75"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Test: the mild hepatic impairment group; Reference: the without hepatic impairment group","nonInferiorityType":"OTHER","nonInferiorityComment":"The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.","paramType":"Ratio of adjusted geometric means","paramValue":"122.70","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"61.33","ciUpperLimit":"245.49"},{"groupIds":["OG000","OG002"],"groupDescription":"Test: the moderate hepatic impairment Group; Reference: the without hepatic impairment group","nonInferiorityType":"OTHER","nonInferiorityComment":"The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.","paramType":"Ratio of adjusted geometric means","paramValue":"282.73","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"141.32","ciUpperLimit":"565.66"},{"groupIds":["OG000","OG003"],"groupDescription":"Test: the severe hepatic impairment group; Reference: the without hepatic impairment group","nonInferiorityType":"OTHER","nonInferiorityComment":"The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.","paramType":"Ratio of adjusted geometric means","paramValue":"640.78","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"320.27","ciUpperLimit":"1282.00"}]},{"type":"PRIMARY","title":"Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)","description":"Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration.","populationDescription":"The analysis population refers to all participants who received at least 1 dose of PF-06882961 and had at least 1 of the PK parameters of interest calculated.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"nanogram*hour per milliliter (ng*hr/mL)","timeFrame":"Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.","groups":[{"id":"OG000","title":"Without Hepatic Impairment","description":"Participants without hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"OG001","title":"Mild Hepatic Impairment","description":"Participants with mild hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"OG002","title":"Moderate Hepatic Impairment","description":"Participants with moderate hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"OG003","title":"Severe Hepatic Impairment","description":"Participants with severe hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"191.2","spread":"84"},{"groupId":"OG001","value":"235.0","spread":"34"},{"groupId":"OG002","value":"542.9","spread":"117"},{"groupId":"OG003","value":"1217","spread":"73"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Test: the mild hepatic impairment group; Reference: the without hepatic impairment group","nonInferiorityType":"OTHER","nonInferiorityComment":"The adjusted ratio and 90% confidence interval from the analysis of variance (ANOVA) model were expressed as percentages.","paramType":"Ratio of adjusted geometric means","paramValue":"122.89","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"61.51","ciUpperLimit":"245.51"},{"groupIds":["OG000","OG002"],"groupDescription":"Test: the moderate hepatic 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represents unbound concentration and C represents total concentration).","populationDescription":"The analysis population refers to all participants who received at least 1 dose of PF-06882961 and had at least 1 of the PK parameters of interest calculated.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio","timeFrame":"Predose (0 hours), and 4 hours post dose on Day 1.","groups":[{"id":"OG000","title":"Without Hepatic Impairment","description":"Participants without hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"OG001","title":"Mild Hepatic Impairment","description":"Participants with mild hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1."},{"id":"OG002","title":"Moderate Hepatic Impairment","description":"Participants with moderate hepatic impairment received a single, oral dose of PF-06882961 20 mg 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Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results."},"pointOfContact":{"title":"Pfizer ClinicalTrials.gov Call Center","organization":"Pfizer Inc.","email":"ClinicalTrials.gov_Inquiries@pfizer.com","phone":"1-800-718-1021"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2020-10-05","uploadDate":"2022-10-24T15:38","filename":"Prot_000.pdf","size":3203505},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan","date":"2020-12-10","uploadDate":"2022-10-24T15:38","filename":"SAP_001.pdf","size":2679286}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"interventionBrowseModule":{"meshes":[{"id":"C000731016","term":"danuglipron"}]}},"hasResults":true}