Effect of Rifampin on the Pharmacokinetics of BAY73-4506

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01322438
First received: March 23, 2011
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Neoplasms
Drug: Regorafenib (BAY73-4506) + rifampin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Pharmacokinetic profile [ Time Frame: after 1 month ] [ Designated as safety issue: No ]
  • Proportion of subjects with adverse event collection [ Time Frame: after 35 days ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: March 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Regorafenib (BAY73-4506) + rifampin
Drug: BAY73-4506 A single 160-mg dose of BAY73-4506 will be administered in the fasted state on Day 1 as four 40 mg tablets. Drug: BAY73-4506 and rifampin 600 mg once a day doses of rifampin will be orally administered after overnight fasting from Day 15 to Day 23. A single 160-mg dose of BAY73-4506 will be administered in the fasted state on Day 21 as four 40 mg tablets.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322438

Locations
United States, Texas
Austin, Texas, United States, 78744
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Clinical Pharmacology, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01322438     History of Changes
Other Study ID Numbers: 15524
Study First Received: March 23, 2011
Last Updated: July 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
healthy volunteers
rifampin
pharmacokinetics
single dose

Additional relevant MeSH terms:
Neoplasms
Rifampin
Antibiotics, Antitubercular
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014