Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Placebo to BI 1060469Drug: BI 1060469
- Registration Number
- NCT01971502
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the single rising dose part (SRD) is to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male subjects. The objective of the food effect part (FE) is to investigate the relative bioavailability of BI 1060469 tablets in healthy male subjects in fed or fasted state.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 68
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 1060469 single rising dose part BI 1060469 single rising doses given as tablet BI 1060469 single rising dose part Placebo to BI 1060469 single rising doses given as tablet BI 1060469 food effect part BI 1060469 given as tablet fasted and fed
- Primary Outcome Measures
Name Time Method Number of subjects with drug- related adverse events. up to 2 weeks
- Secondary Outcome Measures
Name Time Method AUC0-infinity (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 extrapolated to infinity) up to 2 weeks AUC0-tz (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 up to the last quantifiable data point) up to 2 weeks Cmax (maximum measured concentration of BI 1060469 in plasma) up to 2 weeks
Trial Locations
- Locations (1)
1333.1.1 Boehringer Ingelheim Investigational Site
🇩🇪Biberach, Germany