Investigation of the Effect of Food and of Increased Gastric pH on the Relative Bioavailability of Deleobuvir Following Single Oral Administration in Healthy Caucasian and Japanese Subjects (an Open-label, Randomised, Four-way Crossover Study)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUC(0-tz)
研究概览
简要总结
The purpose of this trial is to investigate the effect of food with different fat content and of gastric pH increase (mediated by multiple dosing of omeprazole) on the relative bioavailability of deleobuvir.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（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
BI 207127 fasted
patient to receive BI 207127 as a single dose in fasted state
干预措施: BI 207127 (Drug)
BI 207127 high fat
patient to receive BI 207127 as a single dose after a high fat breakfast
干预措施: BI 207127 high fat (Drug)
BI 207127 low fat
patient to receive BI 207127 as a single dose after a low fat breakfast
干预措施: BI 207127 low fat (Drug)
BI 207127 with Omeprazole
patient to receive BI 207127 as a single dose after 4 days treatment with Omeprazole 40 mg once a day
干预措施: BI 207127 with Omeprazole (Drug)
结局指标
主要结局
AUC(0-tz)
时间窗: 1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration
Area under the concentration-time curve of deleobuvir in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Cmax
时间窗: 1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration
Maximum measured concentration of deleobuvir in plasma (Cmax)
次要结局
- AUC(0-inf)(1 hour (h) before drug administration and 30 minutes (min), 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h and 48h after drug administration)