Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of a Single Oral Dose of BI 1026706 in Healthy Male Subjects (an Open-label, Randomised, Two-period, Two-sequence Crossover Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area Under the Curve of BI 1026706 From 0 to the Last Quantifiable Data Point (AUC0-tz)
研究概览
简要总结
The primary objective of this trial is to investigate the effect of multiple doses of itraconazole on the pharmacokinetics of BI 1026706 given as single dose. The assessment of safety and tolerability of BI 1026706 is an additional objective of this trial. Furthermore, the pharmacokinetics of the metabolite BI 1072668 will be explored.
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
- 18 Years 至 55 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 1026706
Single dose
干预措施: BI 1026706 (Drug)
BI 1026706 + Itraconazole
7 days of itraconazole treatment combined with a single dose of 1026706 on day 4
干预措施: BI 1026706 (Drug)
BI 1026706 + Itraconazole
7 days of itraconazole treatment combined with a single dose of 1026706 on day 4
干预措施: Itraconazole (Drug)
结局指标
主要结局
Area Under the Curve of BI 1026706 From 0 to the Last Quantifiable Data Point (AUC0-tz)
时间窗: -3 hours (h) before drug administration and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration
Area under the concentration-time curve of BI 1026706 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Maximum Concentration of BI 1026706 (Cmax)
时间窗: 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration
Maximum measured concentration of BI 1026706 in plasma (Cmax)
次要结局
- Area Under the Curve of BI 1026706 From 0 Extrapolated to Infinity (AUC0-inf)(-3 hours (h) before drug administration and 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 47h, 71h and 95h after drug administration)