Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1021958 in Healthy Chinese and Japanese Male Volunteers (Placebo-controlled, Randomised and Double-blind Within Dose Groups)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The number (%) of subjects with related adverse events.
研究概览
简要总结
Safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1021958 after single rising doses (SRD) in healthy Asian male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
BI 1021958 dose group 4
subject to receive a tablet containing dose group 4 BI 1021958 single dose
干预措施: Test drug (Drug)
BI 1021958 dose group 3
subject to receive a tablet containing dose group 3 BI 1021958 single dose
干预措施: matching placebo (Drug)
BI 1021958 dose group 1
subject to receive a tablet containing dose group 1 BI 1021958 single dose
干预措施: Test drug (Drug)
BI 1021958 dose group 1
subject to receive a tablet containing dose group 1 BI 1021958 single dose
干预措施: matching placebo (Drug)
BI 1021958 dose group 2
subject to receive a tablet containing dose group 2 BI 1021958 single dose
干预措施: matching placebo (Drug)
BI 1021958 dose group 2
subject to receive a tablet containing dose group 2 BI 1021958 single dose
干预措施: Test drug (Drug)
BI 1021958 dose group 3
subject to receive a tablet containing dose group 3 BI 1021958 single dose
干预措施: Test drug (Drug)
BI 1021958 dose group 4
subject to receive a tablet containing dose group 4 BI 1021958 single dose
干预措施: matching placebo (Drug)
BI 1021958 dose group 5
subject to receive a tablet containing dose group 5 BI 1021958 single dose
干预措施: Test drug (Drug)
BI 1021958 dose group 5
subject to receive a tablet containing dose group 5 BI 1021958 single dose
干预措施: matching placebo (Drug)
结局指标
主要结局
The number (%) of subjects with related adverse events.
时间窗: up to 17 days postdose
次要结局
- AUC0-12 (area under the concentration-time curve of BI 1021958 in plasma over the time interval from the time point 0 until the time point 12 h)(up to day 4 postdose)
- AUC0-24 (area under the concentration-time curve of BI 1021958 in plasma over the time interval from the time point 0 until the time point 24 h)(up to day 4 postdose)
- AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)(up to day 4 postdose)
- AUC0-inf (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity)(up to day 4 postdose)
- Cmax (maximum measured concentration of BI 1021958 in plasma)(up to day 4 postdose)