Trial Condition(s):

Neoplasms

Effect of rifampin on the pharmacokinetics of BAY73-4506

Bayer Identifier:

15524

ClinicalTrials.gov Identifier:

NCT01322438

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

Trial Dates

March2011

June2011

Phase

Could I receive a placebo?

Products

Stivarga (Regorafenib, BAY73-4506)

Accepts Healthy Volunteers

Yes

Where to Participate

Locations

Locations
Locations PPD Development Austin, United States, 78744	Contact Us: E-mail: [email protected] Phone: Not Available

PPD Development

Austin, United States, 78744

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:

Primary Outcome

Pharmacokinetic profile
Timeframe: after 1 month

Proportion of subjects with adverse event collection
Timeframe: after 35 days

Neoplasms

Bayer Identifier:

ClinicalTrials.gov Identifier:

EudraCT Number:

EU CT Number:

Trial Purpose

Key Participation Requirements

sex

age

18 Years

45 Years

Inclusion Criteria

Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

Trial Summary

Enrollment Goal

Trial Dates

Phase

Could I receive a placebo?

Products

Accepts Healthy Volunteers

Where to Participate

Trial Design

Primary Outcome

Additional Information