Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 144807 Powder in Bottle (1 to 1200 mg) in Healthy Male Volunteers in a Randomised, Single-blind, Placebo-controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Number of participants with clinically significant changes in laboratory tests
研究概览
简要总结
This first-in-man trial forms the basis for potential clinical development of BI 144807 in the indications of asthma and allergic rhinitis. The safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 144807 will be assessed 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
- Single
入排标准
- 年龄范围
- 18 Years 至 45 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
BI144807
Subjects receive a single oral dose of BI144807solution
干预措施: BI 144807 (Drug)
Placebo
Subjects receive a single oral dose of placebo solution
干预措施: BI 144807 Placebo (Drug)
结局指标
主要结局
Number of participants with clinically significant changes in laboratory tests
时间窗: up to 14 days postdose
Number of participants tolerating BI 144807
时间窗: up to 14 days postdose
Number of participants with clinically significant changes in ECG
时间窗: up to 14 days postdose
Number of participants with clinically significant changes in physical examination
时间窗: up to 14 days postdose
All adverse events
时间窗: up to 14 days postdose
Number of participants with clinically significant changes in vital signs
时间窗: up to 14 days postdose
次要结局
- Cmax (maximum measured concentration of the analyte in plasma)(up to 72h postdose)
- AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 72h postdose)
- AUC(0-tz) (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)(up to 72h postdose)
- tmax (time from dosing to maximum measured concentration)(up to 72h postdose)
- t1/2 (terminal half-life of the analyte in plasma)(up to 72h postdose)