NCT02126826已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1026706 in Male and Female Healthy Subjects and Patients With Osteoarthritis of the Knee (Randomised, Double-blind, Placebo-controlled Within the Dose Groups, Clinical Phase I)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 58
- 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
- To investigate the safety and tolerability of BI 1026706 in male and female healthy subjects and osteoarthritis (OA) patients following oral administration of repeated rising doses
- To explore the pharmacokinetics after multiple rising doses of BI 1026706 in male and female healthy subjects and OA patients
- The assessment of pharmacodynamics in OA patients
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
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 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 to BI 1026706
Placebo Comparator
Multiple Rising Doses Placebo to BI 1026706
干预措施: Placebo to BI 1026706 (Drug)
BI 1026706
Experimental
Multiple Rising Doses BI 1026706
干预措施: BI 1026706 (Drug)
结局指标
主要结局
Percentage of Subjects With Drug Related Adverse Events
时间窗: From first drug administration until 3 days after last drug administration, 15 days
Percentage of subjects with drug related adverse events (AEs)
次要结局
- Maximum Measured Concentration (Cmax)(1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin)
- Time From Dosing to Maximum Measured Concentration (Tmax)(1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin.)
- Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 24h (AUC0-24)(1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 23h 55min after first drug admin)
- Area Under the Concentration-time Curve Over the Time Interval From 0 Extrapolated to 12h (AUC0-12)(1 hour (h) 30 minutes (min) before first drug admin and 10min, 20min, 30min, 45min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h and 12h after first drug admin)
- Maximum Measured Concentration at Steady-state (Cmax,ss)(5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12)
- Time From Last Dosing to Maximum Measured Concentration at Steady-state (Tmax,ss)(5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12)
- Area Under the Concentration-time Curve at Steady-state (AUCτ,ss)(5 minutes (min) before drug admin on day 12 and 10min, 20min, 30min, 45min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 14h and 24h after drug admin on day 12)
研究者
研究点 (1)
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