protocolSection identificationModule nctId: NCT06327256, orgStudyIdInfo id: 1509-0002, secondaryIdInfos id: 2023-509293-29-00, type: REGISTRY, domain: CTIS, secondaryIdInfos id: U1111-1299-6907, type: REGISTRY, domain: WHO International Clinical Trials Registry Platform (ICTRP), briefTitle: A Study in Healthy People to Test How Well Different Doses of BI 3000202 Are Tolerated and How They Affect the Way the Body Handles Midazolam, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-09-27, completionDateStruct date: 2024-09-27, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Boehringer Ingelheim, class: INDUSTRY, descriptionModule briefSummary: The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following multiple rising doses of BI 3000202 and to investigate the effect of BI 3000202 on the metabolism of midazolam., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The multiple rising dose part of the trial will be conducted in a parallel group assignment. The effect of midazolam interaction will be assessed sequentially., primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: The multiple rising dose part of the trial will be blinded to the participants and investigators . The effect of midazolam will be assessed open label., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: BI 3000202, interventions name: Placebo, interventions name: Midazolam, outcomesModule primaryOutcomes measure: Percentage of subjects with drug-related adverse events, secondaryOutcomes measure: Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 12 hours (AUC0-12), secondaryOutcomes measure: Maximum measured concentration BI 3000202 in plasma (Cmax), secondaryOutcomes measure: Area under the concentration-time curve of BI 3000202 in plasma over a uniform dosing interval τ (AUCτ,ss) at steady state, secondaryOutcomes measure: Maximum measured concentration of BI 3000202 in plasma (Cmax,ss) at steady state, secondaryOutcomes measure: Time from dosing to the maximum measured concentration of BI 3000202 in plasma (tmax,ss) at steady state, secondaryOutcomes 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) after a single dose, secondaryOutcomes measure: Maximum measured concentration of midazolam in plasma (Cmax) after a single dose, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: SGS Life Science Services - Clinical Research, status: RECRUITING, city: Edegem, zip: 2650, country: Belgium, contacts name: Boehringer Ingelheim, role: CONTACT, phone: 080049616, email: belgique@bitrialsupport.com, geoPoint lat: 51.15662, lon: 4.44504, hasResults: False