NCT01763333已完成1 期
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1026706 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability of BI 1026706 (Open-label, Randomised, Four-way Cross-over)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of Subjects With Drug Related Adverse Events
研究概览
简要总结
To investigate the safety, tolerability, pharmacokinetics and the relative bioavailability of BI 1026706
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
2 BI 1026706 bioavailability part
Experimental
bioavailability part of BI 1026706
干预措施: BI 1026706 (Drug)
1 BI 1026706 single rising dose part
Experimental
single rising doses of BI 1026706
干预措施: BI 1026706 Placebo (Drug)
1 BI 1026706 single rising dose part
Experimental
single rising doses of BI 1026706
干预措施: BI 1026706 (Drug)
结局指标
主要结局
Number of Subjects With Drug Related Adverse Events
时间窗: From the first dose of study medication upto 15 days after the day of last intake of study medication, upto 32 days for SRD Part and 30 days for BA Part.
Percentage of subjects with drug related adverse events.
次要结局
- Cmax(-2.0 hours (h) before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing)
- Tmax (Time From Dosing to Maximum Measured Concentration)(-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing)
- AUC0-inf(-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing)
- AUC0- tz(-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing)
- t1/2 (Terminal Half-life of the Analyte in Plasma)(-2.0h before dosing and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing)
- f t1-t2 (SRD-Part)(0-4, 4-8, 8-12, 12-24, 24-48, 48-72 hours)
研究者
研究点 (1)
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