NCT03206632已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 690517 in Healthy Chinese and Japanese Male Subjects (Double-blind, Randomised, Placebo-controlled Group Design)
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
- 56
- 试验地点
- 1
- 主要终点
- Number [N (%)] of subjects with adverse reactions
研究概览
简要总结
The primary objective of this trial is to investigate the safety and tolerability of BI 690517 in healthy Chinese and Japanese male subjects following oral administration of single doses.
Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality as well as the investigation of pharmacodynamic effects following single rising doses of BI 690517.
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 (Participant, Investigator)
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 690517 dose group 2
Experimental
干预措施: BI 690517 (Drug)
BI 690517 dose group 1
Experimental
干预措施: BI 690517 (Drug)
BI 690517 dose group 3
Experimental
干预措施: BI 690517 (Drug)
Placebo
Placebo Comparator
Matching placebo for each dose group
干预措施: Placebo (Drug)
结局指标
主要结局
Number [N (%)] of subjects with adverse reactions
时间窗: up to 336 hours
次要结局
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 48 hours)
研究者
研究点 (1)
Loading locations...
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