Study Completed

Neoplasms

Bayer Identifier:

15524

ClinicalTrials.gov Identifier:

NCT01322438

EudraCT Number:

Not Available

EU CT Number:

Not Available

Effect of rifampin on the pharmacokinetics of BAY73-4506

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.

Key Participants Requirements

Sex

Male

Age

18 - 45 Years

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

Trial Dates

March 2011 - June 2011

Phase

Phase 1

Could I Receive a placebo

Products

Stivarga (Regorafenib, BAY73-4506)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	PPD Development	Austin, 78744, United States

Primary Outcome

Pharmacokinetic profile
Time Frame:
after 1 month
Safety Issue:
No
Proportion of subjects with adverse event collection
Time Frame:
after 35 days
Safety Issue:
Yes

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

Additional Information

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