NCT01835899已完成1 期
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d.for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)
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
- 24
- 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 safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers
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
- 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 1015550 medium dose 2
Experimental
powder for oral solution
干预措施: BI 1015550 (Drug)
Placebo to BI 1015550
Experimental
placebo
干预措施: Placebo (Drug)
BI 1015550 low dose 1
Experimental
powder for oral solution
干预措施: BI 1015550 (Drug)
BI 1015550 low dose 2
Experimental
powder for oral solution
干预措施: BI1015550 (Drug)
BI 1015550 medium dose 1
Experimental
powder for oral solution
干预措施: BI 1015550 (Drug)
结局指标
主要结局
Percentage of Subjects With Drug-related Adverse Events
时间窗: From first drug administration until last drug administration, upto 18 days.
Percentage of subjects with drug related Adverse events, as assessed by the investigator.
次要结局
- AUCt,1(0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration)
- AUC0-infinity(0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.)
- Cmax,ss(311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h.)
- AUCt,ss(311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h.)
- Cmax(0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.)
研究者
研究点 (1)
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