Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects
- Registration Number
- NCT02225626
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Effect of food on the pharmacokinetics of BI 1060469 (formulation tablet) in healthy male subjects as well as to investigate pharmacokinetics, safety and tolerability
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 16
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BI 1060469 fed BI 1060469 tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administr BI 1060469 fasted BI 1060469 tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h
- Primary Outcome Measures
Name Time Method AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) up to 6 days after last drug administration Frequency of subjects with drug-related adverse events up to 7 days after last drug administration Cmax (maximum measured concentration of the analyte in plasma) up to 6 days after last drug administration
- Secondary Outcome Measures
Name Time Method AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) up to 6 days after last drug administration
Trial Locations
- Locations (1)
1333.44.1 Boehringer Ingelheim Investigational Site
🇩🇪Ingelheim, Germany