A Study to Investigate the Effects of BI 1181181 on the Pharmacokinetics of Midazolam, Warfarin, Omeprazole and Digoxin in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 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) of midazolam and omeprazol after each dosing
研究概览
简要总结
To assess the influence of different dose strengths of BI 1181181 on single dose kinetics of midazolam (CYP3A4 probe drug), warfarin (CYP2C9 probe drug), omeprazole (CYP2C19 probe drug) and digoxin (P-gp probe drug)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 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 1
single doses of probe drugs
干预措施: Omeprazole (Drug)
Treatment 3
single dose of midazolam + BI drug
干预措施: Midazolam (Drug)
Treatment 3
single dose of midazolam + BI drug
干预措施: BI 1181181 (Drug)
Treatment 4
single dose of probe drugs + BI drug
干预措施: Omeprazole (Drug)
Treatment 4
single dose of probe drugs + BI drug
干预措施: Midazolam (Drug)
Treatment 4
single dose of probe drugs + BI drug
干预措施: BI 1181181 (Drug)
Treatment 4
single dose of probe drugs + BI drug
干预措施: Warfarin (Drug)
Treatment 5
single dose of digoxin + BI drug
干预措施: BI 1181181 (Drug)
Treatment 5
single dose of digoxin + BI drug
干预措施: Digoxin (Drug)
Treatment 1
single doses of probe drugs
干预措施: Warfarin (Drug)
Treatment 1
single doses of probe drugs
干预措施: Midazolam (Drug)
Treatment 2
single dose of digoxin
干预措施: Digoxin (Drug)
结局指标
主要结局
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) of midazolam and omeprazol after each dosing
时间窗: up to 24 hours
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) of digoxin after each dosing
时间窗: up to 96 hours
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) of warfarin after each dosing
时间窗: up to 120 hours
Cmax (Maximum measured concentration the analyte in plasma) of midazolam and omeprazol after each dosing
时间窗: up to 24 hours
Cmax (Maximum measured concentration the analyte in plasma) of digoxin after each dosing
时间窗: up to 96 hours
Cmax (Maximum measured concentration the analyte in plasma) of warfarin after each dosing
时间窗: up to 120 hours
次要结局
未报告次要终点