Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 1060469 Tablets in Healthy Subjects and Otherwise Healthy Patients With Asthma up to GINA Treatment Step 2 (Phase I, Randomised, Placebo-controlled, Double-blind Within Dose Groups)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Percentage (%) of subjects with drug-related adverse events (AEs)
研究概览
简要总结
The primary objective of this trial is to investigate the safety and tolerability of BI 1060469 in healthy male and female subjects after oral administration of repeated rising doses of 3 mg, 10 mg, 25 mg, 75 mg, 150 mg and 250 mg qd. of 1 day followed by 14 days and in asthmatic male and female patients after oral administration of repeated rising doses of 25 mg and 150 mg qd of 1 day followed by 28 days.
Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality, dose linearity after single and multiple dose segments, pharmacodynamics (PD) of BI 1060469 and to describe the PK/PD relationship.
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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 1060469 Healthy
Multiple rising dose qd for 15 days
干预措施: BI 1060469 Healthy (Drug)
Placebo to BI 1060469
Matching placebo as tablet for 15 days
干预措施: Placebo to BI 1060469 (Drug)
BI 1060469 asthmatics
Multiple rising dose qd for 29 days
干预措施: BI 1060469 asthmatics (Drug)
Placebo to BI 1060469 asthmatics
Matching placebo as tablet for 29 days
干预措施: Placebo to BI 1060469 asthmatics (Drug)
结局指标
主要结局
Percentage (%) of subjects with drug-related adverse events (AEs)
时间窗: Day 1 to 29 or Day 1 to Day 43 (end of trial)
次要结局
- AUCt,ss (area under the concentration-time curve of BI 1060469 in plasma at steady state over a uniform dosing interval t)(0 to 672 hours or 0 to 1008 hours)
- Cpre,N (predose concentration of BI 1060469 in plasma immediately before administration of the Nth dose after N-1 doses were administered)(0 to 672 hours or 0 to 1008 hours)
- AUCt,1 (area under the concentration-time curve of BI 1060469 in plasma over a uniform dosing interval t after administration of the first dose)(0 to 672 hours or 0 to 1008 hours)
- AUC0-infinity (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 extrapolated to infinity)(0 to 672 hours or 0 to 1008 hours)
- Cmax (maximum measured concentration of BI 1060469 in plasma)(0 to 672 hours or 0 to 1008 hours)
- Cmax,ss (maximum measured concentration of BI 1060469 in plasma at steady state)(0 to 672 hours or 0 to 1008 hours)
- Linearity index (LI)(0 to 672 hours or 0 to 1008 hours)