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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- AUC0-infinity of BI 409306 and Its Metabolites
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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).
干预措施: 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).
干预措施: 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.
干预措施: 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.
干预措施: 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).
干预措施: 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).
干预措施: BI 409306 (Drug)
结局指标
主要结局
AUC0-infinity of BI 409306 and Its Metabolites
时间窗: 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
时间窗: 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
次要结局
- 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)