NCT01971502已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of BI 1060469 in Healthy Male Volunteers (Single-blind, Placebo-controlled, Randomised, Partly Fixed-sequence, Parallel Group Design) and Effect of Food on the Bioavailability of BI 1060469 (Open-label, Randomised, Two-way Cross-over)
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
- 68
- 试验地点
- 1
- 主要终点
- Number of subjects with drug- related adverse events.
研究概览
简要总结
The objective of the single rising dose part (SRD) is to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male subjects. The objective of the food effect part (FE) is to investigate the relative bioavailability of BI 1060469 tablets in healthy male subjects in fed or fasted state.
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 50 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 single rising dose part
Experimental
single rising doses given as tablet
干预措施: Placebo to BI 1060469 (Drug)
BI 1060469 single rising dose part
Experimental
single rising doses given as tablet
干预措施: BI 1060469 (Drug)
BI 1060469 food effect part
Experimental
given as tablet fasted and fed
干预措施: BI 1060469 (Drug)
结局指标
主要结局
Number of subjects with drug- related adverse events.
时间窗: up to 2 weeks
次要结局
- AUC0-infinity (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 extrapolated to infinity)(up to 2 weeks)
- AUC0-tz (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 up to the last quantifiable data point)(up to 2 weeks)
- Cmax (maximum measured concentration of BI 1060469 in plasma)(up to 2 weeks)
研究者
研究点 (1)
Loading locations...
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