Safety and Pharmacokinetics of Multiple Rising Oral Doses of BI 224436 ZW (Powder in Bottle Formulation) at 12.5 mg q24h, 12.5 mg q12h, 12.5 mg q8h, 25 mg q12h, 25 mg q8h, 50 mg q12h, 37.5 mg q8h and 50 mg q8h Dose Levels for 10 Days in Healthy Male Volunteers (Randomized, Double-blind Placebo-controlled Within Dose Groups)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Changes in blood pressure
研究概览
简要总结
To investigate the safety and pharmacokinetic of BI 224436 in healthy male volunteers following oral administration of repeated doses for 10 days within 8 dosing regimens.
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
Placebo
Matching placebo in dosing regimen 1-8
干预措施: BI 224436 (Drug)
Placebo
Matching placebo in dosing regimen 1-8
干预措施: Placebo (Drug)
BI 224436 dosing regimen 1
Dosing regimen 1
干预措施: BI 224436 (Drug)
BI 224436 dosing regimen 2
Dosing regimen 2
干预措施: BI 224436 (Drug)
BI 224436 dosing regimen 3
Dosing regimen 3
干预措施: BI 224436 (Drug)
BI 224436 dosing regimen 4
Dosing regimen 4
干预措施: BI 224436 (Drug)
BI 224436 dosing regimen 5
Dosing regimen 5
干预措施: BI 224436 (Drug)
BI 224436 dosing regimen 6
Dosing regimen 6
干预措施: BI 224436 (Drug)
BI 224436 dosing regimen 7
Dosing regimen 7
干预措施: BI 224436 (Drug)
BI 224436 dosing regimen 8
Dosing regimen 8
干预措施: BI 224436 (Drug)
结局指标
主要结局
Changes in blood pressure
时间窗: 1 month
Changes in pulse rate
时间窗: 1 month
Changes in 12-lead ECG
时间窗: 1 month
Changes in clinical laboratory test parameters
时间窗: 1 month
Adverse events
时间窗: 1 month
次要结局
- Cmax,ss (maximum measured concentration of the analyte in plasma at steady-state over a uniform dosing interval t)(10 days)
- tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady-state)(10 Days)
- Cmin,ss (minimum concentration of the analyte in plasma at steady-state over a uniform dosing interval t)(10 days)
- AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady-state over a uniform dosing interval t)(13 days)
- t1/2,ss (terminal half-life of the analyte in plasma at steady-state)(13 days)
- CL/F,ss (apparent clearance of the analyte in the plasma at steady-state following extravascular multiple dose administration)(13 days)