{"protocolSection":{"identificationModule":{"nctId":"NCT06367153","orgStudyIdInfo":{"id":"1447-0007"},"secondaryIdInfos":[{"id":"2023-510461-10-00","type":"REGISTRY","domain":"CTIS"},{"id":"U1111-1303-9187","type":"REGISTRY","domain":"WHO International Clinical Trials Registry Platform (ICTRP)"},{"id":"2023","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2023"}],"organization":{"fullName":"Boehringer Ingelheim","class":"INDUSTRY"},"briefTitle":"A Study in Healthy Men and Women to Test Whether BI 1569912 Influences the Amount of Repaglinide, Midazolam and Bupropion in the Blood","officialTitle":"The Effect of Multiple Doses of BI 1569912 on the Single-dose Pharmacokinetics of Repaglinide, Midazolam and Bupropion Following Oral Administration in Healthy Male and Female Subjects (an Open-label, 2-period Fixed-sequence Trial)"},"statusModule":{"statusVerifiedDate":"2025-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2024-05-15","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2024-08-20","type":"ACTUAL"},"completionDateStruct":{"date":"2024-08-20","type":"ACTUAL"},"studyFirstSubmitDate":"2024-04-11","studyFirstSubmitQcDate":"2024-04-11","studyFirstPostDateStruct":{"date":"2024-04-16","type":"ACTUAL"},"resultsFirstSubmitDate":"2026-04-29","resultsFirstSubmitQcDate":"2026-04-29","resultsFirstPostDateStruct":{"date":"2026-05-22","type":"ACTUAL"},"lastUpdateSubmitDate":"2026-04-29","lastUpdatePostDateStruct":{"date":"2026-05-22","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Boehringer Ingelheim","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The main objective of this trial is to investigate the effect of multiple oral doses of BI 1569912 on the pharmacokinetics of a single oral dose of repaglinide, midazolam and bupropion (i.e. sensitive CYP2C8, CYP3A4 and CYP2B6 substrates)."},"conditionsModule":{"conditions":["Healthy"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"NA","interventionModel":"CROSSOVER","interventionModelDescription":"Patients cross over from test treatment (T) to reference treatment (R) (two periods, fixed sequence).","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":18,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Reference treatment (R), then test treatment (T)","type":"EXPERIMENTAL","description":"Reference Treatment (R): On the morning of Day (D) 1, healthy participants received a single tablet of 0.5 milligrams (mg) of repaglinide orally. On the morning of D2, participants took a single dose of 2 mg of midazolam solution for injection orally. On the morning of D3, participants received orally a single extended-release tablet of 150 mg of bupropion. All medications were administered after an overnight fast of at least 10 hours.\n\nTest Treatment (T): Healthy participants received in the morning, for 21 days (D-14 to D7), the intended BI 1569912 daily dose. On the morning of D1, participants took after the administration of BI 1569912, a single tablet of 0.5 mg of repaglinide orally. On the morning of D2, participants took, after the administration of BI 1569912, a single dose of 2 mg of midazolam solution for injection orally. On the morning of D3, participants received orally a single extended-release tablet of 150 mg of bupropion after BI 1569912.\n\nNo washout period occurred.","interventionNames":["Drug: BI 1569912","Drug: Repaglinide","Drug: Midazolam","Drug: Bupropion"]}],"interventions":[{"type":"DRUG","name":"BI 1569912","description":"Intended dose of BI 1569912","armGroupLabels":["Reference treatment (R), then test treatment (T)"]},{"type":"DRUG","name":"Repaglinide","description":"0.5 mg tablet","armGroupLabels":["Reference treatment (R), then test treatment (T)"]},{"type":"DRUG","name":"Midazolam","description":"2 mg solution for injection","armGroupLabels":["Reference treatment (R), then test treatment (T)"]},{"type":"DRUG","name":"Bupropion","description":"150 mg extended-release tablet","armGroupLabels":["Reference treatment (R), then test treatment (T)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)","description":"This outcome measured the area under the concentration-time curve of repaglinide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","timeFrame":"Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter."},{"measure":"Area Under Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)","description":"This outcome measured the area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","timeFrame":"Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter."},{"measure":"Area Under the Concentration-time Curve of S-bupropion in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)","description":"This outcome measured the area under the concentration-time curve of chiral form S-bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when bupropion was administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","timeFrame":"Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter."},{"measure":"Area Under the Concentration-time Curve of Total Bupropion in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)","description":"This outcome measured the area under the concentration-time curve of total bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when bupropion was administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","timeFrame":"Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter."}],"secondaryOutcomes":[{"measure":"Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)","description":"This outcome measured the area under the concentration-time curve of repaglinide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","timeFrame":"Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter."},{"measure":"Maximum Measured Concentration of Repaglinide in Plasma (Cmax)","description":"This outcome measured maximum measured concentration of repaglinide in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","timeFrame":"Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter."},{"measure":"Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)","description":"This outcome measured the area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when administered alone or co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","timeFrame":"Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter."},{"measure":"Maximum Measured Concentration of Midazolam in Plasma (Cmax)","description":"This outcome measured maximum measured concentration of midazolam in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","timeFrame":"Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter."},{"measure":"Area Under the Concentration-time Curve of S-bupropion in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)","description":"This outcome measured the area under the concentration-time curve of the chiral form S-bupropion in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when bupropion was administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","timeFrame":"Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter."},{"measure":"Maximum Measured Concentration of S-bupropion in Plasma (Cmax)","description":"This outcome measured maximum measured concentration of the chiral form S-bupropion in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","timeFrame":"Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter."},{"measure":"Area Under the Concentration-time Curve of Total Bupropion in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)","description":"This outcome measured the area under the concentration-time curve of total bupropion in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when bupropion was administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","timeFrame":"Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter."},{"measure":"Maximum Measured Concentration of Total Bupropion in Plasma (Cmax)","description":"This outcome measured maximum measured concentration of total bupropion in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","timeFrame":"Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, standardized mental and neurological assessment, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests without clinically significant abnormalities\n* Age of 18 to 55 years (inclusive)\n* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)\n* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial\n* Either male subjects or female subjects who meet the following criteria requiring highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion:\n\n  * Use of adequate contraception, i.e. use of condom (male subjects or male partners of female subjects) plus any of the following methods (female subjects or female partners of male subjects): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives), , surgically sterilised (including bilateral tubal occlusion/ligation, hysterectomy, bilateral oophorectomy) or postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle stimulating hormone (FSH) above 40 U/L is confirmatory)\n  * Sexually abstinent (considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments)\n  * Vasectomised male subjects or male partners of female subjects (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (i.e. use of condom) and provided that the partner is the sole sexual partner of the trial participant Unprotected sexual intercourse (i.e. without use of condom) of a male subject with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion. Female subjects should not participate in egg donation from the first trial medication administration, for the duration of the study and for at least 30 days after trial completion.\n\nExclusion Criteria:\n\n* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator\n* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)\n* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the Upper limit of normal (ULN) after repeated measurements\n* Any evidence of a concomitant disease assessed as clinically relevant by the investigator\n* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders\n* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)\n* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke, bulimia or anorexia, or bipolar mood disorder), and other relevant neurological or psychiatric disorders\n* History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"55 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"SGS Life Science Services - Clinical Research","city":"Edegem","zip":"2650","country":"Belgium","geoPoint":{"lat":51.15662,"lon":4.44504}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Related Info","url":"https://www.mystudywindow.com"}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to:\n\nhttps://www.mystudywindow.com/msw/datatransparency"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that they strictly met all inclusion and none of the exclusion criteria. Participants were not to be allocated to a treatment group if any of the entry criteria were violated.","recruitmentDetails":"This was a non-randomized, open-label, 2-period trial in healthy male and female participants in order to test the influence of multiple doses of BI 1569912 on the pharmacokinetics of repaglinide, midazolam, and bupropion (sensitive CYP2C8, CYP3A4 and CYP2B6 substrates).","groups":[{"id":"FG000","title":"Reference Treatment (R), Then Test Treatment (T)","description":"Reference (R) Treatment: On the morning of Day 1, healthy participants received a single tablet of 0.5 milligrams (mg) of repaglinide orally. On the morning of Day 2, participants took a single dose of 2 mg of midazolam solution for injection orally. On the morning of Day 3, participants received orally a single extended-release tablet of 150 mg of bupropion. All medications were administered after an overnight fast of at least 10 hours.\n\nTest Treatment (T): Healthy participants received in the morning, for 21 days (Day -14 to Day 7), the intended BI 1569912 daily dose, orally after an overnight fast of at least 10 hours. On the morning of Day 1, participants received after the administration of BI 1569912, a single tablet of 0.5 mg of repaglinide orally. On the morning of Day 2, participants took, after the administration of BI 1569912, a single dose of 2 mg of midazolam solution for injection orally. On the morning of Day 3, participants received orally a single extended-release tablet of 150 mg of bupropion after BI 1569912.\n\nNo washout period occurred between treatment periods."}],"periods":[{"title":"Reference (R) treatment period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"18"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"17"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]},{"title":"Test (T) treatment period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"17"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"17"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Treated set (TS): all participants who were treated with at least one dose of trial drug.","groups":[{"id":"BG000","title":"Reference Treatment (R), Then Test Treatment (T)","description":"Reference (R) Treatment: On the morning of Day 1, healthy participants received a single tablet of 0.5 milligrams (mg) of repaglinide orally. On the morning of Day 2, participants took a single dose of 2 mg of midazolam solution for injection orally. On the morning of Day 3, participants received orally a single extended-release tablet of 150 mg of bupropion. All medications were administered after an overnight fast of at least 10 hours.\n\nTest Treatment (T): Healthy participants received in the morning, for 21 days (Day -14 to Day 7), the intended BI 1569912 daily dose, orally after an overnight fast of at least 10 hours. On the morning of Day 1, participants received after the administration of BI 1569912, a single tablet of 0.5 mg of repaglinide orally. On the morning of Day 2, participants took, after the administration of BI 1569912, a single dose of 2 mg of midazolam solution for injection orally. On the morning of Day 3, participants received orally a single extended-release tablet of 150 mg of bupropion after BI 1569912.\n\nNo washout period occurred between treatment periods."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"18"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"35.4","spread":"9.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"10"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"8"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"17"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"18"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)","description":"This outcome measured the area under the concentration-time curve of repaglinide in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","populationDescription":"Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"hour*picomole/liter","timeFrame":"Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.","groups":[{"id":"OG000","title":"Repaglinide 0.5 mg (R1)","description":"Healthy participants received a single tablet of 0.5 milligrams (mg) of repaglinide orally on the morning of Day 1 of the Reference (R) treatment period, after an overnight fast of at least 10 hours."},{"id":"OG001","title":"Repaglinide 0.5 mg + BI 1569912 (T1)","description":"Healthy participants received after the administration of BI 1569912 dose, a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21882.61","spread":"NA","comment":"Adjusted geometric standard error = 1.10"},{"groupId":"OG001","value":"27332.41","spread":"NA","comment":"Adjusted geometric standard error = 1.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","nonInferiorityType":"OTHER","paramType":"Adjusted gMean ratio [%]","paramValue":"124.90","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"115.78","ciUpperLimit":"134.75","estimateComment":"Adjusted geometric mean (gMean) ratio is calculated as Repaglinide 0.5 mg + BI 1569912 (T1)/Repaglinide 0.5 mg (R1) \\*100\n\nIntra-individual geometric coefficient of variation (gCV) \\[%\\] = 12.7"}]},{"type":"PRIMARY","title":"Area Under Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)","description":"This outcome measured the area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","populationDescription":"Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"hour*picomole/liter","timeFrame":"Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.","groups":[{"id":"OG000","title":"Midazolam 2 mg (R2)","description":"Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours."},{"id":"OG001","title":"Midazolam 2 mg + BI 1569912 (T2)","description":"Healthy participants received after the administration of the intended dose of BI 1569912, a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the test treatment period (T)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"57471.40","spread":"NA","comment":"Adjusted geometric standard error = 1.10"},{"groupId":"OG001","value":"69127.73","spread":"NA","comment":"Adjusted geometric standard error = 1.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","nonInferiorityType":"OTHER","paramType":"Adjusted gMean ratio [%]","paramValue":"120.28","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"108.66","ciUpperLimit":"133.15","estimateComment":"Adjusted geometric mean (gMean) ratio is calculated as Midazolam 2 mg + BI 1569912 (T2)/Midazolam 2 mg (R2) \\*100\n\nIntra-individual geometric coefficient of variation (gCV) \\[%\\] = 17.1"}]},{"type":"SECONDARY","title":"Area Under the Concentration-time Curve of Repaglinide in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)","description":"This outcome measured the area under the concentration-time curve of repaglinide in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","populationDescription":"Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"hour*picomole/liter","timeFrame":"Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.","groups":[{"id":"OG000","title":"Repaglinide 0.5 mg (R)","description":"Healthy participants received a single tablet of 0.5 milligrams (mg) of repaglinide orally on the morning of Day 1 of the Reference (R) treatment period, after an overnight fast of at least 10 hours."},{"id":"OG001","title":"Repaglinide 0.5 mg + BI 1569912 20 mg (T)","description":"Healthy participants received one hour after the administration of two 10 milligrams (mg) tablets of BI 1569912 orally (20 mg total daily dose), a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21329.40","spread":"NA","comment":"Adjusted geometric standard error = 1.10"},{"groupId":"OG001","value":"25968.07","spread":"NA","comment":"Adjusted geometric standard error = 1.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","nonInferiorityType":"OTHER","paramType":"Adjusted gMean ratio [%]","paramValue":"121.75","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"112.80","ciUpperLimit":"131.41","estimateComment":"Adjusted geometric mean (gMean) ratio is calculated as Repaglinide 0.5 mg + BI 1569912 (T1)/Repaglinide 0.5 mg (R1) \\*100\n\nIntra-individual geometric coefficient of variation (gCV) \\[%\\] = 12.8"}]},{"type":"PRIMARY","title":"Area Under the Concentration-time Curve of S-bupropion in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)","description":"This outcome measured the area under the concentration-time curve of chiral form S-bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when bupropion was administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","populationDescription":"Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"hour*nanomole/liter","timeFrame":"Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.","groups":[{"id":"OG000","title":"Bupropion 150 mg (R3)","description":"Healthy participants received a single extended-release tablet of 150 mg of bupropion orally on the morning of Day 3 of the reference period (R), after an overnight fast of at least 10 hours."},{"id":"OG001","title":"Bupropion 150 mg + BI 1569912 (T3)","description":"Healthy participants received after the administration of the intended dose of BI 1569912, a single extended-release tablet of 150 mg of bupropion orally on the morning of Day 3 of the test treatment period (T)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"302.02","spread":"NA","comment":"Adjusted geometric standard error = 1.11"},{"groupId":"OG001","value":"312.11","spread":"NA","comment":"Adjusted geometric standard error = 1.11"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","nonInferiorityType":"OTHER","paramType":"Adjusted gMean ratio [%]","paramValue":"103.34","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"93.98","ciUpperLimit":"113.64","estimateComment":"Adjusted geometric mean (gMean) ratio is calculated as Bupropion 150 mg + BI 1569912 (T3)/Bupropion 150 mg (R3) \\*100\n\nIntra-individual geometric coefficient of variation (gCV) \\[%\\] = 16.0"}]},{"type":"SECONDARY","title":"Maximum Measured Concentration of Repaglinide in Plasma (Cmax)","description":"This outcome measured maximum measured concentration of repaglinide in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","populationDescription":"Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"picomole/liter","timeFrame":"Within 3 hours (h) before repaglinide administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.","groups":[{"id":"OG000","title":"Repaglinide 0.5 mg (R)","description":"Healthy participants received a single tablet of 0.5 milligrams (mg) of repaglinide orally on the morning of Day 1 of the Reference (R) treatment period, after an overnight fast of at least 10 hours."},{"id":"OG001","title":"Repaglinide 0.5 mg + BI 1569912 20 mg (T)","description":"Healthy participants received one hour after the administration of two 10 milligrams (mg) tablets of BI 1569912 orally (20 mg total daily dose), a single tablet of 0.5 mg of repaglinide orally on the morning of Day 1 of the Test (T) treatment period."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16770.42","spread":"NA","comment":"Adjusted geometric standard error = 1.10"},{"groupId":"OG001","value":"19025.09","spread":"NA","comment":"Adjusted geometric standard error = 1.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","nonInferiorityType":"OTHER","paramType":"Adjusted gMean ratio [%]","paramValue":"113.44","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"95.84","ciUpperLimit":"134.29","estimateComment":"Adjusted geometric mean (gMean) ratio is calculated as Repaglinide 0.5 mg + BI 1569912 (T1)/Repaglinide 0.5 mg (R1) \\*100\n\nIntra-individual geometric coefficient of variation (gCV) \\[%\\] = 28.8"}]},{"type":"SECONDARY","title":"Area Under the Concentration-time Curve of Midazolam in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)","description":"This outcome measured the area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when administered alone or co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","populationDescription":"Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"hour*picomole/liter","timeFrame":"Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.","groups":[{"id":"OG000","title":"Midazolam 2 mg (R2)","description":"Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours."},{"id":"OG001","title":"Midazolam 2 mg + BI 1569912 20 mg (T2)","description":"Healthy participants received one hour after the administration of two 10 milligrams (mg) tablets of BI 1569912 orally (20 mg total daily dose), a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the test treatment period (T)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"54970.22","spread":"NA","comment":"Adjusted geometric standard error = 1.09"},{"groupId":"OG001","value":"65317.58","spread":"NA","comment":"Adjusted geometric standard error = 1.09"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","nonInferiorityType":"OTHER","paramType":"Adjusted gMean ratio [%]","paramValue":"118.82","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"107.15","ciUpperLimit":"131.77","estimateComment":"Adjusted geometric mean (gMean) ratio is calculated as Midazolam 2 mg + BI 1569912 (T2)/Midazolam 2 mg (R2) \\*100\n\nIntra-individual geometric coefficient of variation (gCV) \\[%\\] = 17.4"}]},{"type":"SECONDARY","title":"Maximum Measured Concentration of Midazolam in Plasma (Cmax)","description":"This outcome measured maximum measured concentration of midazolam in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","populationDescription":"Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"picomole/liter","timeFrame":"Within 3 hours (h) before midazolam administration and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 h thereafter.","groups":[{"id":"OG000","title":"Midazolam 2 mg (R2)","description":"Healthy participants received a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the reference period (R), after an overnight fast of at least 10 hours."},{"id":"OG001","title":"Midazolam 2 mg + BI 1569912 20 mg (T2)","description":"Healthy participants received one hour after the administration of two 10 milligrams (mg) tablets of BI 1569912 orally (20 mg total daily dose), a single dose of 2 mg of midazolam solution for injection orally on the morning of Day 2 of the test treatment period (T)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26797.94","spread":"NA","comment":"Adjusted geometric standard error = 1.10"},{"groupId":"OG001","value":"33379.74","spread":"NA","comment":"Adjusted geometric standard error = 1.10"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","nonInferiorityType":"OTHER","paramType":"Adjusted gMean ratio [%]","paramValue":"124.56","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"104.56","ciUpperLimit":"148.38","estimateComment":"Adjusted geometric mean (gMean) ratio is calculated as Midazolam 2 mg + BI 1569912 (T2)/Midazolam 2 mg (R2) \\*100\n\nIntra-individual geometric coefficient of variation (gCV) \\[%\\] = 29.9"}]},{"type":"PRIMARY","title":"Area Under the Concentration-time Curve of Total Bupropion in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)","description":"This outcome measured the area under the concentration-time curve of total bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞), when bupropion was administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","populationDescription":"Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"hour*nanomole/liter","timeFrame":"Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.","groups":[{"id":"OG000","title":"Bupropion 150 mg (R3)","description":"Healthy participants received a single extended-release tablet of 150 mg of bupropion orally on the morning of Day 3 of the reference period (R), after an overnight fast of at least 10 hours."},{"id":"OG001","title":"Bupropion 150 mg + BI 1569912 (T3)","description":"Healthy participants received after the administration of the intended dose of BI 1569912, a single extended-release tablet of 150 mg of bupropion orally on the morning of Day 3 of the test treatment period (T)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2665.85","spread":"NA","comment":"Adjusted geometric standard error = 1.09"},{"groupId":"OG001","value":"2901.12","spread":"NA","comment":"Adjusted geometric standard error = 1.09"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","nonInferiorityType":"OTHER","paramType":"Adjusted gMean ratio [%]","paramValue":"108.83","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"98.63","ciUpperLimit":"120.07","estimateComment":"Adjusted geometric mean (gMean) ratio is calculated as Bupropion 150 mg + BI 1569912 (T3)/Bupropion 150 mg (R3) \\*100\n\nIntra-individual geometric coefficient of variation (gCV) \\[%\\] = 16.5"}]},{"type":"SECONDARY","title":"Area Under the Concentration-time Curve of S-bupropion in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)","description":"This outcome measured the area under the concentration-time curve of the chiral form S-bupropion in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when bupropion was administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","populationDescription":"Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"hour*nanomole/liter","timeFrame":"Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.","groups":[{"id":"OG000","title":"Buproprion 150 mg (R3)","description":"Healthy participants received a single extended-release tablet of 150 mg of bupropion orally on the morning of Day 3 of the reference period (R), after an overnight fast of at least 10 hours."},{"id":"OG001","title":"Bupropion 150 mg + BI 1569912 20 mg (T3)","description":"Healthy participants received one hour after the administration of two 10 milligrams (mg) tablets of BI 1569912 orally (20 mg total daily dose), a single extended-release tablet of 150 mg of bupropion orally on the morning of Day 3 of the test treatment period (T)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"258.69","spread":"NA","comment":"Adjusted geometric standard error = 1.12"},{"groupId":"OG001","value":"277.01","spread":"NA","comment":"Adjusted geometric standard error = 1.12"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","nonInferiorityType":"OTHER","paramType":"Adjusted gMean ratio [%]","paramValue":"107.08","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"94.67","ciUpperLimit":"121.13","estimateComment":"Adjusted geometric mean (gMean) ratio is calculated as Bupropion 150 mg + BI 1569912 (T3)/Bupropion 150 mg (R3) \\*100\n\nIntra-individual geometric coefficient of variation (gCV) \\[%\\] = 20.8"}]},{"type":"SECONDARY","title":"Maximum Measured Concentration of S-bupropion in Plasma (Cmax)","description":"This outcome measured maximum measured concentration of the chiral form S-bupropion in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","populationDescription":"Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"nanomole/liter","timeFrame":"Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.","groups":[{"id":"OG000","title":"Buproprion 150 mg (R3)","description":"Healthy participants received a single extended-release tablet of 150 mg of bupropion orally on the morning of Day 3 of the reference period (R), after an overnight fast of at least 10 hours."},{"id":"OG001","title":"Bupropion 150 mg + BI 1569912 20 mg (T3)","description":"Healthy participants received one hour after the administration of two 10 milligrams (mg) tablets of BI 1569912 orally (20 mg total daily dose), a single extended-release tablet of 150 mg of bupropion orally on the morning of Day 3 of the test treatment period (T)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"24.44","spread":"NA","comment":"Adjusted geometric standard error = 1.13"},{"groupId":"OG001","value":"23.19","spread":"NA","comment":"Adjusted geometric standard error = 1.13"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","nonInferiorityType":"OTHER","paramType":"Adjusted gMean ratio [%]","paramValue":"94.85","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"78.20","ciUpperLimit":"115.05","estimateComment":"Adjusted geometric mean (gMean) ratio is calculated as Bupropion 150 mg + BI 1569912 (T3)/Bupropion 150 mg (R3) \\*100\n\nIntra-individual geometric coefficient of variation (gCV) \\[%\\] = 33.1"}]},{"type":"SECONDARY","title":"Area Under the Concentration-time Curve of Total Bupropion in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)","description":"This outcome measured the area under the concentration-time curve of total bupropion in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz), when bupropion was administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","populationDescription":"Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"hour*nanomole/liter","timeFrame":"Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.","groups":[{"id":"OG000","title":"Buproprion 150 mg (R3)","description":"Healthy participants received a single extended-release tablet of 150 mg of bupropion orally on the morning of Day 3 of the reference period (R), after an overnight fast of at least 10 hours."},{"id":"OG001","title":"Bupropion 150 mg + BI 1569912 20 mg (T3)","description":"Healthy participants received one hour after the administration of two 10 milligrams (mg) tablets of BI 1569912 orally (20 mg total daily dose), a single extended-release tablet of 150 mg of bupropion orally on the morning of Day 3 of the test treatment period (T)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2622.90","spread":"NA","comment":"Adjusted geometric standard error = 1.09"},{"groupId":"OG001","value":"2856.51","spread":"NA","comment":"Adjusted geometric standard error = 1.09"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","nonInferiorityType":"OTHER","paramType":"Adjusted gMean ratio [%]","paramValue":"108.91","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"98.59","ciUpperLimit":"120.30","estimateComment":"Adjusted geometric mean (gMean) ratio is calculated as Bupropion 150 mg + BI 1569912 (T3)/Bupropion 150 mg (R3) \\*100\n\nIntra-individual geometric coefficient of variation (gCV) \\[%\\] = 16.7"}]},{"type":"SECONDARY","title":"Maximum Measured Concentration of Total Bupropion in Plasma (Cmax)","description":"This outcome measured maximum measured concentration of total bupropion in plasma (Cmax), when administered alone and when co-administered at BI 1569912 steady-state.\n\nThe statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","populationDescription":"Pharmacokinetic (PK) parameter analysis set (PKS): all participants who were treated with at least one dose of trial drug and who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability. One participant discontinued treatment due to an adverse event during the reference treatment period and only received repaglinide.","reportingStatus":"POSTED","paramType":"GEOMETRIC_LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"nanomole/liter","timeFrame":"Within 3 hours (h) before bupropion administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 h thereafter.","groups":[{"id":"OG000","title":"Buproprion 150 mg (R3)","description":"Healthy participants received a single extended-release tablet of 150 mg of bupropion orally on the morning of Day 3 of the reference period (R), after an overnight fast of at least 10 hours."},{"id":"OG001","title":"Bupropion 150 mg + BI 1569912 20 mg (T3)","description":"Healthy participants received one hour after the administration of two 10 milligrams (mg) tablets of BI 1569912 orally (20 mg total daily dose), a single extended-release tablet of 150 mg of bupropion orally on the morning of Day 3 of the test treatment period (T)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"261.76","spread":"NA","comment":"Adjusted geometric standard error = 1.09"},{"groupId":"OG001","value":"277.76","spread":"NA","comment":"Adjusted geometric standard error = 1.09"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The statistical model used was an analysis of variance (ANOVA) accounting for the following sources of variation: participant and treatment. The effect 'participant' was considered as random, whereas the effect 'treatment' was considered as fixed.","nonInferiorityType":"OTHER","paramType":"Adjusted gMean ratio [%]","paramValue":"106.11","ciPctValue":"90","ciNumSides":"TWO_SIDED","ciLowerLimit":"89.45","ciUpperLimit":"125.88","estimateComment":"Adjusted geometric mean (gMean) ratio is calculated as Bupropion 150 mg + BI 1569912 (T3)/Bupropion 150 mg (R3) \\*100\n\nIntra-individual geometric coefficient of variation (gCV) \\[%\\] = 29.1"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"All-cause mortality: From first drug administration until individual end of study. Up to 39 days. Adverse event reporting: From first drug administration until last drug administration, plus residual effect period. 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