Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses of BI 691751 in Healthy Male Volunteers in a Randomised, Single-blind, Placebo-controlled Design (Part I) and Investigation of Relative Bioavailability of BI 691751 Given as Tablet and Oral Solution to Healthy Male Subjects in an Open, Randomised, Single-dose, Single Period Parallel Group Design (Part II).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Cmax (Part II)
研究概览
简要总结
To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I).
To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution (part II)
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
BI 691751 dose 7 (part I)
single dose given as oral solution
干预措施: BI 691751 (Drug)
BI 691751dose 1 (part I)
single dose given as oral solution
干预措施: BI 691751 (Drug)
BI 691751 dose 5 (part I)
single dose given as oral solution
干预措施: BI 691751 (Drug)
BI 691751 dose 6 (part I)
single dose given as oral solution
干预措施: BI 691751 (Drug)
BI 691751 dose 2 (part I)
single dose given as oral solution
干预措施: BI 691751 (Drug)
BI 691751 dose 3 (part I)
single dose given as oral solution
干预措施: BI 691751 (Drug)
BI 691751 dose 4 (part I)
single dose given as oral solution
干预措施: BI 691751 (Drug)
Placebo (part I)
placebo solution
干预措施: Placebo (Drug)
BI 691751 tablet (part II)
single dose given as 1 tablet
干预措施: BI 691751 (Drug)
BI 691751 solution (part II)
single dose given as oral solution
干预措施: BI 691751 (Drug)
结局指标
主要结局
Cmax (Part II)
时间窗: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug administration
Cmax (maximum measured concentration of the analyte of BI 691751 in plasma) (part II)
Frequency of Subjects With Drug-related Adverse Events (Part I)
时间窗: Part I: 'Day1 to Day21 for Dose 1, 2,3 &4 and Day1 to Day45 for Dose group 5,6 & 7
Frequency of subjects with drug-related Adverse Events (AEs) (Part I)
AUC0-72h (Part II)
时间窗: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration
AUC0-72h (area under the concentration-time curve of the analyte of BI 691751 in plasma over the time interval from 0 to 72 h) (part II). PPS-BA included all subjects in the TS who were randomised to the BA part, who provided at least one observation for at least one primary endpoint, had no important protocol violations relevant for the statistical evaluation of BA and did not experience emesis at or before twice the median tmax.
次要结局
- t1/2 (Part I)(for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h)
- Cmax (Part I)(for dose 1 & 2: up to 168h, for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h)
- AUC0-infinity (Part I)(for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h)
- AUC0-tz(Part 1: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 7: up to 720h; Part 2: up to 720h)
- Tmax (Part I)(for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h)
