Effect of Rifampin on the Pharmacokinetics of BAY73-4506
- Registration Number
- NCT01322438
- Lead Sponsor
- Bayer
- Brief Summary
The purpose of this study is to see if giving rifampin, a marketed antibiotic, changes how your body absorbs and distributes BAY73-4506.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- 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.
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Exclusion Criteria
- Clinically significant disease or condition
- Recent serious infection
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Regorafenib (BAY73-4506) + rifampin -
- Primary Outcome Measures
Name Time Method Pharmacokinetic profile after 1 month Proportion of subjects with adverse event collection after 35 days
- Secondary Outcome Measures
Name Time Method