NCT02694354已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 685509 in Healthy Male Subjects
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
- 16
- 试验地点
- 1
- 主要终点
- Number [N(%)] of the subject with drug-related Adverse Events
研究概览
简要总结
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising oral doses of BI 685509
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 685509
Experimental
干预措施: BI 685509 (Drug)
Placebo
Placebo Comparator
matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number [N(%)] of the subject with drug-related Adverse Events
时间窗: 0-48 hours
次要结局
- AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(0-24 hours)
- Cmax (maximum concentration of the analyte in plasma)(0-24 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Single Rising Dose Study of BI 690517 in Healthy VolunteersHealthyNCT02891148Boehringer Ingelheim50
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 10773 in Healthy Male SubjectsHealthyNCT02172170Boehringer Ingelheim72
已完成
1 期
Safety of Single Rising Doses and Relative Bioavailability of BI 691751HealthyNCT01843972Boehringer Ingelheim81
已完成
1 期
Phase I Study of AbGn-168H in Healthy Male VolunteersHealthyNCT01378364Boehringer Ingelheim48
已完成
1 期
Safety and Pharmacokinetics of Single Rising Doses of BI 705564 and Food Effect on BI 705564 in Healthy Male SubjectsHealthyNCT03123185Boehringer Ingelheim91