NCT01651598已完成1 期
Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Multiple Rising Doses of BI 144807 Powder for Oral Drinking Solution Over a Period of 14 Days in Otherwise Healthy Controlled Asthmatic Subjects in a Randomised, Double-blind, Placebo-controlled 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
- 57
- 试验地点
- 1
- 主要终点
- Number (% patients) of drug-related adverse events
研究概览
简要总结
In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of multiple dose administration of BI 144807 will be investigated in otherwise healthy, controlled asthmatic patients
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 55 Years（Adult）
- 性别
- All
- 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
BI 144807
Experimental
Subjects receive multiple BID doses of BI 144807 solution
干预措施: BI 144807 (Drug)
Placebo
Placebo Comparator
Subjects receive multiple BID doses of Placebo solution
干预措施: Placebo to BI 144807 (Drug)
结局指标
主要结局
Number (% patients) of drug-related adverse events
时间窗: up to 28 days
次要结局
- Time from last dosing to maximum measured concentration (Tmax,ss)(up to 72 hours after last dose)
- Area under the concentration-time curve of the analyte in plasma over the time interval from t1 to t2 after administration of the first dose (AUCt1-t2)(up to 24 hours after first dose)
- Time from first dosing to maximum measured concentration (Tmax)(up to 24 hours after first dose)
- Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t (AUCt,ss)(up to 72 hours after last dose)
- Terminal half-life of the analyte in plasma at steady state (t1/2,ss)(up to 72 hours after last dose)
- Maximum measured concentration of the analyte in plasma after first dose (Cmax)(up to 24 hours after first dose)
- Maximum measured concentration of the analyte in plasma after last dose (Cmax,ss)(up to 72 hours after last dose)
- Terminal half-life of the analyte in plasma after the first dose (t1/2)(up to 24 hours after first dose)
- RA,Cmax (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of Cmax at steady state and after single dose)(up to 72 hours after last dose)
- RA,AUC (Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval τ, expressed as ratio of AUC at steady state and after single dose)(up to 72 hours after last dose)
研究者
研究点 (1)
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