Drug Drug Interaction Trial With Strong CYP3A4 Inhibitor (Itraconazole) in CYP2C19 Extensive Metabolizers and Poor Metabolizers
- Registration Number
- NCT02248259
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The objective of the current study is to evaluate the effect of once daily itraconazole on the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Extensive Metabolisers: Test / Ref BI 409306 Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were: * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). Extensive Metabolisers: Ref / Test BI 409306 Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were: * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. Poor Metabolisers: Ref / Test BI 409306 Participants who were poor metabolisers received two treatments in a randomised order, the treatments were: * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. Poor Metabolisers: Test / Ref BI 409306 Participants who were poor metabolisers received two treatments in a randomised order, the treatments were: * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). Extensive Metabolisers: Ref / Test Itraconazole Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were: * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. Poor Metabolisers: Ref / Test Itraconazole Participants who were poor metabolisers received two treatments in a randomised order, the treatments were: * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. Extensive Metabolisers: Test / Ref Itraconazole Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were: * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). Poor Metabolisers: Test / Ref Itraconazole Participants who were poor metabolisers received two treatments in a randomised order, the treatments were: * Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. * Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
- Primary Outcome Measures
Name Time Method AUC0-infinity of BI 409306 and Its Metabolites 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) of BI 409306 and its metabolites CD 13896 and CD 14084
Cmax of BI 409306 and Its Metabolites 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration Maximum measured concentration of the analyte in plasma (Cmax) of BI 409306 and its metabolites CD 13896 and CD 14084
- Secondary Outcome Measures
Name Time Method t1/2 of BI 409306 and Its Metabolites 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration Terminal half-life of the analyte in plasma (t1/2) of BI 409306 and its metabolites CD 13896 and CD 14084
AUC0-tz of BI 409306 and Its Metabolites 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable plasma concentration (AUC0-tz) of BI 409306 and its metabolites CD 13896 and CD 14084
Tmax of BI 409306 and Its Metabolites 1 hour (h) before drug administration and 10minutes (min), 20min, 30min, 45min, 1h, 1h 30min, 2h, 3h, 4h, 7h, 10h, 12h, 14h, 24h, 48h and 72h (only for test treatment) after drug administration Time from dosing to the maximum concentration of the analyte in plasma (tmax) of BI 409306 and its metabolites CD 13896 and CD 14084
Trial Locations
- Locations (1)
1289.23.8201 Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of