Effect of Food on the Pharmacokinetics of BI 1060469 (Formulation Tablet) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
研究概览
简要总结
Effect of food on the pharmacokinetics of BI 1060469 (formulation tablet) in healthy male subjects as well as to investigate pharmacokinetics, safety and tolerability
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
- 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
BI 1060469 fed
tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administr
干预措施: BI 1060469 (Drug)
BI 1060469 fasted
tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h
干预措施: BI 1060469 (Drug)
结局指标
主要结局
AUC 0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
时间窗: up to 6 days after last drug administration
Frequency of subjects with drug-related adverse events
时间窗: up to 7 days after last drug administration
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: up to 6 days after last drug administration
次要结局
- AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 6 days after last drug administration)