Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1 mg as Drinking Solution, and 5, 20, 60, 150, 300, 500 mg as Tablets) of BI 1021958 in Healthy Male Volunteers (Placebo-controlled, Randomised and Single Blind Within Dose Groups), Including Investigation of the Effect of Food on the Bioavailability of BI 1021958 (Open-label, Randomised, Two-way Cross-over)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Number of participants with significant changes from baseline laboratory measurements
研究概览
简要总结
Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)
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
- Single
入排标准
- 年龄范围
- 18 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
Single rising dose (SRD) part
干预措施: BI 1021958 (Drug)
BI 1021958 (Food effect)
Food effect part (FE)
干预措施: BI 1021958 (Drug)
Placebo to BI 1021958
Matching placebo as drinking solution and tablets
干预措施: Placebo to BI 1021958 (Drug)
结局指标
主要结局
Number of participants with significant changes from baseline laboratory measurements
时间窗: up to 14 days postdose
Assessment of tolerability by investigator
时间窗: up to 14 days postdose
Number of participants with clinically relevant findings in physical examination
时间窗: up to 14 days postdose
Number of participants with clinically relevant findings in vital signs
时间窗: up to 14 days postdose
Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results
时间窗: up to 14 days postdose
Number of participants with adverse events
时间窗: up to 14 days postdose
次要结局
- area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)(up to 72h postdose)
- Cmax (maximum measured concentration of BI 1021958 in plasma)(up to 72h 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 72h postdose)