The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02254148
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To assess the influence of BI 187004 on kinetics of cytochrome P450 (CYP) and P glycoprotein (P-gp) probe drugs as a means of predicting drug-drug interactions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment BI 187004 single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004 Treatment omeprazole single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004 Treatment midazolam single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004 Treatment digoxin single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004 Treatment caffeine single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004 Treatment warfarin single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004 Treatment metoprolol single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004
- Primary Outcome Measures
Name Time Method Cmax (Maximum measured concentration of the analyte in plasma) for probe substrates up to 143 hours postdose AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) for probe substrates up to 143 hours postdose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
1307.19.1 Boehringer Ingelheim Investigational Site
🇩🇪Biberach, Germany