Trial Condition(s):

Neoplasms

Effect of rifampin on the pharmacokinetics of BAY73-4506

Bayer Identifier:

15524

ClinicalTrials.gov Identifier:

NCT01322438

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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 Summary

Enrollment Goal
24
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

PPD Development

Austin, United States, 78744

Status
Completed
 

Trial Design