NCT02891148已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 690517 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
- 50
- 试验地点
- 1
- 主要终点
- The percentage of subjects with adverse reactions, analysed as investigator defined drug-related adverse events.
研究概览
简要总结
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses of BI 690517
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 690517
Experimental
干预措施: BI 690517 (Drug)
结局指标
主要结局
The percentage of subjects with adverse reactions, analysed as investigator defined drug-related adverse events.
时间窗: From the first drug administration until end of the trial, up to 14 days
The percentage of subjects with adverse reactions, analysed as investigator defined drug-related adverse events (AEs).
次要结局
- Area under the concentration-time curve of the BI-690517 in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)(Pharmacokinetic blood samples: 1:30 hours before drug administration and 30 minutes, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 hours after drug administration.)
- Maximum measured concentration of the BI-690517 in plasma (Cmax)(PK blood samples: 1:30 hours before drug administration and 30 minutes, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 hours after drug administration.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Investigation of Single Rising Doses of BI 685509HealthyNCT02694354Boehringer Ingelheim16
已完成
1 期
Safety of Single Rising Doses and Relative Bioavailability of BI 691751HealthyNCT01843972Boehringer Ingelheim81
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
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