Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 691751 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With Drug-related Adverse Events
研究概览
简要总结
It is the objective of this MRD trial to investigate pharmacokinetics, pharmcodynamics, safety and tolerability of rising doses BI 691751 over a treatment period of 14 days to support the further clinical development of this LTA4H-inhibitor. Special emphasis will be given to detect potential effects of BI 691751 on heart rate.
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 50 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 1
multiple dose given over 14 days
干预措施: BI 691751 (Drug)
BI 691751 Dose 2
multiple dose given over 14 days
干预措施: BI 691751 (Drug)
BI 691751 Dose 3
multiple dose given over 14 days
干预措施: BI 691751 (Drug)
BI 691751 Dose 4
multiple dose given over 14 days
干预措施: BI 691751 (Drug)
BI 691751 Dose 5
multiple dose given over 14 days
干预措施: BI 691751 (Drug)
BI 691751 Dose 6
multiple dose given over 14 days
干预措施: BI 691751 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects With Drug-related Adverse Events
时间窗: From the time of administration of the respective treatment until 21 days after last administration of study drug or start of the post-study phase to the respective treatment, up to 35 days
Percentage of subjects with drug-related Adverse events (AEs)
次要结局
- 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 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration)
- Cmax (Maximum Measured Concentration of the Analyte Inplasma)(0 minutes (min), 10min, 20min, 40min, 1 hour (h), 1h 30min, 2h, 3h, 4h, 6h, 8h, 10h, 12h and 24h after first drug administration)
- AUCt,ss (Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)(312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration)
- Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State Over a Uniform Dosing Interval t)(312 hours (h), 312 h 10 minutes (min), 312h 20min, 312h 40min, 313, 313h 30min, 314h, 315h, 316h, 318h, 320h, 322h, 324h and 336h after first drug administration)