The Effect of Multiple Doses of BI 187004 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P-glycoprotein Substrate (Digoxin) Administered Orally in an Open-label, One-sequence Trial in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax (Maximum measured concentration of the analyte in plasma) for probe substrates
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 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
Treatment
single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004
干预措施: midazolam (Drug)
Treatment
single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004
干预措施: caffeine (Drug)
Treatment
single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004
干预措施: digoxin (Drug)
Treatment
single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004
干预措施: warfarin (Drug)
Treatment
single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004
干预措施: omeprazole (Drug)
Treatment
single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004
干预措施: BI 187004 (Drug)
Treatment
single dose of CYP 450 substrates and a P-gp substrate + multiple doses of BI 187004
干预措施: metoprolol (Drug)
结局指标
主要结局
Cmax (Maximum measured concentration of the analyte in plasma) for probe substrates
时间窗: 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
时间窗: up to 143 hours postdose
次要结局
未报告次要终点