Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets Given Orally Once Daily for 12 Days to Young and Elderly Healthy Male and Female Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Study)(Part 1) and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 After Oral Administration in the Morning Versus Oral Administration in the Evening in Young Healthy Male and Female Volunteers (Randomised, Two-sequence, Open, Two Period, Two-way Cross Over) (Part 2)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- frequency [N(%)] of subjects with drug related adverse events (AEs)
研究概览
简要总结
The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI 425809 given in the morning and in the evening.
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 85 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
BI 425809 very low dose - part I
Part I only - very low dose tablet, oral administration with 240 ml water, over 14 days
干预措施: BI 425809 (Drug)
BI 425809 low dose - part I
Part I - low dose tablet, oral administration with 240 ml water, over 14 days
干预措施: BI 425809 (Drug)
BI 425809 medium dose - part I
Part I only - medium dose tablet, oral administration with 240 ml water, over 14 days
干预措施: BI 425809 (Drug)
BI 425809 high dose -part I
Part I only - high dose tablet, oral administration with 240 ml water, over 14 days
干预措施: BI 425809 (Drug)
BI 425809 low dose - part II
Part II - one low dose tablet on day 1 of visit 2 and 2a
干预措施: BI 425809 (Drug)
BI 425809 very high dose -part I
Part I only - very high dose tablet, oral administration with 240 ml water, over 14 days
干预措施: BI 425809 (Drug)
Placebo - part I
Part I only - placebo tablet, oral administration with 240ml water, over 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
frequency [N(%)] of subjects with drug related adverse events (AEs)
时间窗: up to 25 days after first drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) only part II
时间窗: up to 96 hours
Cmax (maximum measured concentration of the analyte in plasma) only part II
时间窗: up to 96 hours
次要结局
- AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t)(up to 216 hours after last dose)
- Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)(up to 216 hours after last dose)
- AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) only part II(up to 96 hours)
- AUCt 0-24(area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)(up to 72 hours after first dose)
- Cmax (maximum measured concentration of the analyte in plasma)(up to 72 hours after first dose)