To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Placebo to BI 416970Drug: BI 416970
- Registration Number
- NCT02093819
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics (PK) of single rising doses of BI 416970. A further objective is to assess the influence of CYP2C9 phenotype on the PK of BI 416970.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
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 416970 single rising dose part Placebo to BI 416970 single rising dose given as tablet BI 416970 single rising dose part BI 416970 single rising dose given as tablet
- Primary Outcome Measures
Name Time Method Percentage of Subjects With Drug-related Adverse Events AEs were recorded throughout the trial Percentage of subjects with drug-related adverse events
- Secondary Outcome Measures
Name Time Method Cmax (Maximum Measured Concentration of the Analyte in Plasma) 2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration Cmax (maximum measured concentration of the analyte in plasma)
AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) 2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Trial Locations
- Locations (1)
1345.1.1 Boehringer Ingelheim Investigational Site
🇩🇪Biberach, Germany