A Study in Healthy Men to Test How Different Doses of BI 3000202 Are Tolerated and How Food Influences the Amount of BI 3000202 in the Blood
- Registration Number
- NCT05945888
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202.
The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 68
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SRD part: Treatment group BI 3000202 - SRD part: Placebo group Placebo matching BI 3000202 - FE part: Treatment sequence reference (R) - test (T) BI 3000202 - FE part: Treatment sequence test (T) - reference (R) BI 3000202 -
- Primary Outcome Measures
Name Time Method SRD part: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator. up to 14 days This is expressed as the percentage of subjects treated with investigational drug who experience such an event.
FE part: Area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours (AUC 0-24) up to 3 days FE part: Maximum measured concentration of the analyte in plasma (Cmax) up to 3 days
- Secondary Outcome Measures
Name Time Method SRD part: Cmax up to 3 days SRD part: AUC 0-24 up to 3 days FE part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) up to 3 days
Trial Locations
- Locations (1)
Humanpharmakologisches Zentrum Biberach
🇩🇪Biberach, Germany