check_circleStudy 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
  • - 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.
  • - Clinically significant disease or condition
    - Recent serious infection

Trial summary

Enrollment Goal
24
Trial Dates
March 2011 - June 2011
Phase
Phase 1
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
PPD DevelopmentAustin, 78744, United States

Primary Outcome

  • Pharmacokinetic profile
    date_rangeTime Frame:
    after 1 month
    enhanced_encryption
    Safety Issue:
    No
  • Proportion of subjects with adverse event collection
    date_rangeTime Frame:
    after 35 days
    enhanced_encryption
    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
1

Additional Information

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