Effect of Rifampin on the Pharmacokinetics of BAY73-4506

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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

Key facts

Study ID

NCT01322438

Run by

Bayer

People needed

24

Starts

2011-03-01

Expected to finish

2011-06-01

Last updated by the study team

2014-12-19

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Clinically significant disease or condition
• Recent serious infection

Where it is running

• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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