Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 411034 (PIB) in Healthy Male Volunteers (Randomised, Single-blind, Placebocontrolled Within Dose Groups, Phase I Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Number of Participants With Drug Related AEs
研究概览
简要总结
The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.
The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).
Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)
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
- Single
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 411034 low dose - group 1
Solution for oral administration
干预措施: BI 411034 (Drug)
BI 411034 low dose - group 2
Solution for oral administration
干预措施: BI 411034 (Drug)
BI 411034 medium dose - group 3
Solution for oral administration
干预措施: BI 411034 (Drug)
BI 411034 medium dose - group 4
Solution for oral administration
干预措施: BI 411034 (Drug)
BI 411034 medium dose - group 5
Solution for oral administration
干预措施: BI 411034 (Drug)
BI 411034 high dose - group 6
Solution for oral administration
干预措施: BI 411034 (Drug)
BI 411034 high dose - group 7
Solution for oral administration
干预措施: BI 411034 (Drug)
BI 411034 high dose - group 8
Solution for oral administration
干预措施: BI 411034 (Drug)
Placebo
Solution for oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Drug Related AEs
时间窗: From drug administration until end of trial examination, up to 13 days
Number of participants with drug related adverse events (AEs)
Clinically Relevant Abnormalities for Physical Examinations, Vital Signs, ECG, Laboratory Tests
时间窗: From drug administration until end of trial examination, up to 13 days
Clinically relevant abnormalities for physical examinations, vital signs (blood pressure, pulse rate, oral body temperature, orthostasis test), 12-lead electrocardiogram (ECG) and clinical laboratory tests. Clinically relevant abnormalities are reported by the investigator as adverse events (AEs).
次要结局
- Maximum Measured Concentration (Cmax )(2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration)
- Time to Maximum Measured Concentration (Tmax)(2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration)
- Area Under the Curve From 0 Extrapolated to Infinity (AUC0-infinity)(2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration)
- Amount of Analyte Eliminated in Urine From 0h to 4h (Ae0-4)(2 hours (h) before drug administration and 10 minutes (min), 20min, 30min, 45min, 1h 15min, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, and 72h after drug administration)