Effect of Rifampin on the Pharmacokinetics of BAY73-4506

Bayer

Status and phase: Completed; Phase 1

Conditions: Neoplasms

Treatments: Drug: Regorafenib (BAY73-4506) + rifampin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01322438

15524

Details and patient eligibility

About

The purpose of this study is to see if giving rifampin, a marketed antibiotic, changes how your body absorbs and distributes BAY73-4506.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Exclusion criteria

• Clinically significant disease or condition
• Recent serious infection

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Regorafenib (BAY73-4506) + rifampin