NCT01195688已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (1-700 mg) of BI 638683 Powder in Bottle (PiB) in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled 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
- 63
- 试验地点
- 1
- 主要终点
- Safety of BI 638683 will be assessed in a descriptive way.
研究概览
简要总结
The primary objective of the current study is to investigate the safety and tolerability of BI 638683 in healthy male volunteers following oral administration of single rising doses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
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 638683
Experimental
1 single dose per subject as oral solution
干预措施: BI 638683 or placebo (Drug)
Placebo solution
Placebo Comparator
1 single dose per subject as oral solution
干预措施: Placebo solution (Drug)
结局指标
主要结局
Safety of BI 638683 will be assessed in a descriptive way.
时间窗: up to 14 days post treatment
Tolerability of BI 638683 will be assessed in a descriptive way.
时间窗: up to 14 days post treatment
次要结局
- To assess pharmacodynamics of BI 638683.(up to 5 days post study drug administration)
- To assess pharmacokinetics of BI 638683.(up to 5 days post study drug administration)
研究者
研究点 (1)
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