Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 1181181 Given Orally q.d. for 10 Days in Young Healthy Male and Elderly Healthy Male/Female Volunteers (Randomized, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- frequency [N (%)] of subjects with drug-related adverse events
研究概览
简要总结
The primary objective of the current study is to investigate the safety and tolerability of BI 1181181 in healthy young male and elderly male and female volunteers following oral administration of repeated rising doses of BI 1181181, given once daily over 10 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1181181.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older 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
Matching placebo in healthy young
Matching placebo for 10 days
干预措施: Matching placebo (Drug)
BI 1181181 healthy young
Medium doses as tablets q.d. for 10 days
干预措施: BI 1181181 Healthy young (Drug)
BI 1181181 healthy elderly
Medium doses as tablets q.d. for 10 days
干预措施: BI 1181181 healthy elderly (Drug)
Matching placebo in healthy elderly
Matching placebo for 10 days
干预措施: Matching placebo (Drug)
结局指标
主要结局
frequency [N (%)] of subjects with drug-related adverse events
时间窗: days 1 to 24
次要结局
- Cmax,ss (maximum measured concentration of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t) after administration of the last dose(0 to 336 hours)
- AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)(0 to 336 hours)
- AUCt,ss (area under the concentration-time curve of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t after the administration of the last dose(0 to 336 hours)
- Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after administration of the last dose(0 to 336 hours)
- Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose(0 to 336 hours)
- AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the administration of the last dose(0 to 336 hours)
