A Study in Healthy People to Test How 3 Different Formulations of BI 764198 Are Taken up in the Body and How This is Influenced by Food
Phase 1
Not yet recruiting
- Conditions
- Healthy
- Interventions
- Drug: BI 764198, formulation 1Drug: BI 764198, formulation 2Drug: BI 764198, formulation 3
- Registration Number
- NCT06955754
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This trial aims to investigate the relative bioavailability of three different oral formulations of BI 764198 and how this is influenced by food.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment sequence A BI 764198, formulation 1 T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state Treatment sequence B BI 764198, formulation 3 T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state Treatment sequence A BI 764198, formulation 2 T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state Treatment sequence B BI 764198, formulation 2 T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state Treatment sequence A BI 764198, formulation 3 T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state Treatment sequence B BI 764198, formulation 1 T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state Treatment sequence C BI 764198, formulation 1 T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast Treatment sequence C BI 764198, formulation 2 T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast Treatment sequence C BI 764198, formulation 3 T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast Treatment sequence D BI 764198, formulation 1 R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state Treatment sequence D BI 764198, formulation 2 R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state Treatment sequence D BI 764198, formulation 3 R - reference treatment: BI 764198 formulation 1 administered to subjects in fasted state T3 - test treatment 3: BI 764198 formulation 3 administered to subjects in fasting state T2 - test treatment 2: BI 764198 formulation 2 administered to subjects after a high-fat, high-calorie breakfast T1 - test treatment 1: BI 764198 formulation 2 administered to subjects in fasting state
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) up to 4 days Maximum measured concentration of the analyte in plasma (Cmax) up to 4 days
- Secondary Outcome Measures
Name Time Method Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point, dose normalized (AUC0-tz, norm) up to 4 days Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity, dose normalized (AUC0-∞, norm) up to 4 days Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) up to 4 days Maximum measured concentration of the analyte in plasma, dose normalised (Cmax, norm) up to 4 days