NCT02093819已完成1 期
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 416970 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, Investigation of Relative Bioavailability of BI 416970 (Open-label, Randomised, Three-way Cross-over) and Assessment of Safety and Exposure of BI 416970 in CYP2C9 Genotyped Volunteers (Open-label, Single-dose)
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
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With Drug-related Adverse Events
研究概览
简要总结
To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics (PK) of single rising doses of BI 416970. A further objective is to assess the influence of CYP2C9 phenotype on the PK of BI 416970.
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 416970 single rising dose part
Experimental
single rising dose given as tablet
干预措施: Placebo to BI 416970 (Drug)
BI 416970 single rising dose part
Experimental
single rising dose given as tablet
干预措施: BI 416970 (Drug)
结局指标
主要结局
Percentage of Subjects With Drug-related Adverse Events
时间窗: AEs were recorded throughout the trial
Percentage of subjects with drug-related adverse events
次要结局
- Cmax (Maximum Measured Concentration of the Analyte in Plasma)(2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration)
- AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)(2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration)
研究者
研究点 (1)
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