Trial Condition(s):
Neoplasms
Effect of rifampin on the pharmacokinetics of BAY73-4506
Bayer Identifier:
15524
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT 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
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
| Locations | Status | |
|---|---|---|
Locations PPD Development Austin, United States, 78744 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Phase 1, Non-Randomized, Open Label Study to Determine the Effect of Rifampin on the Pharmacokinetics of a Single Oral Dose of 160 mg Regorafenib (BAY73-4506) in Healthy Volunteers
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Pharmacokinetic profileTimeframe: after 1 month
- Proportion of subjects with adverse event collectionTimeframe: after 35 days
Additional Information
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