Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability and the Effect of Food on the Pharmacokinetics of BI 1181181(Open-label, Randomised, Three-way Cross-over Design)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Cmax (maximum measured concentration of the analyte in plasma)
研究概览
简要总结
To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI 1181181 (Bioavailability/Food effect (BA/FE) part)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
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
1 BI 1181181 single rising dose part
single rising doses of BI 1181181
干预措施: BI 1181181 (Drug)
1 BI 1181181 single rising dose part
single rising doses of BI 1181181
干预措施: Placebo to BI 1181181 (Drug)
2 BI 1181181 bioavailability part
bioavailability, food effect part of BI 11881181
干预措施: BI 1181181, R (Drug)
2 BI 1181181 bioavailability part
bioavailability, food effect part of BI 11881181
干预措施: BI 1181181, T2 (Drug)
2 BI 1181181 bioavailability part
bioavailability, food effect part of BI 11881181
干预措施: BI 1181181, T1 (Drug)
结局指标
主要结局
Cmax (maximum measured concentration of the analyte in plasma)
时间窗: up to 72 h
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)
时间窗: up to 72 h
Number (%) of subjects with drug-related adverse events (AEs)
时间窗: up to 72 h
次要结局
- Cmax (maximum measured concentration of the analyte in plasma)(up to 72 h)
- t1/2 (terminal half-life of the analyte in plasma)(up to 72 h)
- Aet1-t2 (Amount of analyte that is eliminated in urine from the time point t1 to timepoint t2 after single dose administration)(up to 72 h)
- tmax (time from dosing to maximum measured concentration of the analyte in plasma)(up to 72 h)
- AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 72 h)