NCT02383888已完成1 期
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 425809 in Healthy Japanese and Chinese Male Subjects (Randomized, Double-blind, Placebo-controlled Design Within Dose Groups)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- the number of subjects with drug-related Adverse Events
研究概览
简要总结
To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy Chinese and Japanese male subjects following the administration of single rising oral doses and further to explore the pharmacokinetics (PK) including dose proportionality of BI 425809 after single dosing of product.
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
Matching placebo for each dose groups
Placebo Comparator
干预措施: Placebo (Drug)
BI 425809 Active dose group 1
Experimental
干预措施: BI 425809 (Drug)
BI 425809 Active dose group 2
Experimental
干预措施: BI 425809 (Drug)
Bi 425809 Active dose group 3
Experimental
干预措施: BI 425809 (Drug)
结局指标
主要结局
the number of subjects with drug-related Adverse Events
时间窗: up to 18 days post dosing
次要结局
- maximum measured concentration of the analyte in plasma(up to 9 days post doing)
- area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable plasma concentration(up to 9 days post doing)
- time from dosing to the maximum concentration of the analyte in plasma(up to 9 days post doing)
- area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity(up to 9 days post doing)
- terminal half-life of the analyte in plasma(up to 9 days post doing)
研究者
研究点 (1)
Loading locations...
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