NCT00420615已完成1 期
An Open Label Phase I Study to Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies
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
- 34
- 试验地点
- 1
- 主要终点
- To evaluate the effects of patupilone on the pharmacokinetics of omeprazole in patients with advanced malignancies
研究概览
简要总结
The purpose of this study is to evaluate the potential inhibitory effects of patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Patupilone and Omeprazole
Experimental
patupiloe + omeprazole
干预措施: Patupilone and Omeprazole (Drug)
patupilone + midalzolam
Experimental
patupilone + midalzolam
干预措施: Patupilone + Midalzolam (Drug)
结局指标
主要结局
To evaluate the effects of patupilone on the pharmacokinetics of omeprazole in patients with advanced malignancies
时间窗: Day 1 (0.33h (20m), 0.67h (40m), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h)
To evaluate the effects of patupilone on the pharmacokinetics of midazolam in patients with advanced malignancies.
时间窗: Day 1 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h), Day 29 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h)
次要结局
- To evaluate the safety and tolerability of Patupilone when administered concomitantly with omeprazole in patients with advanced malignancies.(at each visit (week 1, week 2, week 5, and end of study))
- To evaluate the safety and tolerability of Patupilone when administered concomitantly with midazolam in patients with advanced malignancies.(at each visit (week 1, week 2, week 5, and end of study))
研究者
研究点 (1)
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