NCT01322438已完成1 期
A Phase 1, Non-Randomized, Open Label Study to Determine the Effect of Rifampin on the Pharmacokinetics of a Single Oral Dose of 160 mg Regorafenib (BAY73-4506) in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 24
- 主要终点
- Pharmacokinetic profile
研究概览
简要总结
The purpose of this study is to see if giving rifampin, a marketed antibiotic, changes how your body absorbs and distributes BAY73-4506.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subject
- •Age: 18 to 45 years (inclusive) at the first screening examination / visit
- •Body mass index (BMI): 18 to 32 kg/m² (inclusive)
- •Ability to understand and follow study-related instructions
- •Subjects enrolled in this study must use adequate barrier birth control measures prior to, during the course of the study, and 3 months after the last administration of regorafenib. An adequate contraception includes the use of condoms or a vasectomy. In addition, adequate birth control measures for the subject's partner is required, such as a hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices, bilateral tubal ligation, or hysterectomy.
排除标准
- •Clinically significant disease or condition
- •Recent serious infection
研究组 & 干预措施
Arm 1
Experimental
干预措施: Regorafenib (BAY73-4506) + rifampin (Drug)
结局指标
主要结局
Pharmacokinetic profile
时间窗: after 1 month
Proportion of subjects with adverse event collection
时间窗: after 35 days
次要结局
未报告次要终点
研究者
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