NCT02183545已完成1 期
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1060469 in Healthy Asian Male Volunteers in a Randomized, Double-blind, Placebo-controlled 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
- 80
- 试验地点
- 2
- 主要终点
- number of subjects with drug-related adverse events
研究概览
简要总结
The objective of this single rising dose study (SRD) is to investigate safety, tolerability, and pharmacokinetics of single rising doses of BI 1060469 in healthy Asian male subjects.
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
- 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 1060469
Experimental
single rising doses given as tablet
干预措施: BI 1060469 (Drug)
Placebo
Placebo Comparator
given as tablet (matching placebo of BI 1060469)
干预措施: Placebo (Drug)
结局指标
主要结局
number of subjects with drug-related adverse events
时间窗: up to 14 days after drug administration
次要结局
- Maximum concentration of BI 1060469 (Cmax)(up to 72 hours after drug administration)
- Area Under the concentration-time curve of BI 1060469 over time interval from 0 interpolated to infinity ((AUC0-infinity)(up to 72 hours after drug administration)
- Area Under the concentration-time curve of BI 1060469 (AUC0- tz)(up to 72 hours after drug administration)
研究者
研究点 (2)
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