Open-label, Randomised, Two-way Crossover Study to Assess the Effect of Once Daily Itraconazole on the Pharmacokinetics of BI 409306 After a Single Oral Dose in Healthy Male Volunteers Genotyped as Poor and Extensive Metabolizers of CYP2C19
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- AUC0-infinity of BI 409306 and Its Metabolites
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Extensive Metabolisers: Ref / Test
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.
Intervention: BI 409306 (Drug)
Extensive Metabolisers: Ref / Test
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.
Intervention: Itraconazole (Drug)
Poor Metabolisers: Ref / Test
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.
Intervention: BI 409306 (Drug)
Poor Metabolisers: Ref / Test
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.
Intervention: Itraconazole (Drug)
Extensive Metabolisers: Test / Ref
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).
Intervention: BI 409306 (Drug)
Extensive Metabolisers: Test / Ref
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).
Intervention: Itraconazole (Drug)
Poor Metabolisers: Test / Ref
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).
Intervention: BI 409306 (Drug)
Poor Metabolisers: Test / Ref
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).
Intervention: Itraconazole (Drug)
Outcomes
Primary Outcomes
AUC0-infinity of BI 409306 and Its Metabolites
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)