Overview

Effect of Rifampin on the Pharmacokinetics of BAY73-4506

Status:
Completed
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to see if giving rifampin, a marketed antibiotic, changes how your body absorbs and distributes BAY73-4506.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Bayer
Treatments:
Rifampin
Criteria
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