NCT05183347已完成1 期
Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1291583 in Healthy Male Japanese Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
研究概览
简要总结
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1291583 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SRD: Dose Group 1
Experimental
SRD: single-rising dose
干预措施: BI 1291583 (Drug)
SRD: Dose Group 2
Experimental
SRD: single-rising dose
干预措施: BI 1291583 (Drug)
SRD: Dose Group 3
Experimental
SRD: single-rising dose
干预措施: BI 1291583 (Drug)
MD: Dose Group 4
Experimental
MD: multiple doses
干预措施: BI 1291583 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
时间窗: up to 65 days
次要结局
- SRD: Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(up to 29 days)
- MD: After the last dose: Maximum measured concentration of BI 1291583 in plasma at steady state (Cmax,ss)(at day 28)
- SRD: Maximum measured concentration of BI 1291583 in plasma (Cmax)(up to 29 days)
- MD: After the first dose: Area under the concentration-time curve of BI 1291583 in plasma over a uniform dosing interval τ (AUCτ,1)(up to 24 hours)
- MD: After the first dose: Maximum measured concentration of BI 1291583 in plasma (Cmax,1)(up to 24 hours)
- MD: After the last dose: Area under the concentration-time curve of BI 1291583 in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)(at day 28)
研究者
研究点 (1)
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