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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


Phase 1
18 Years
45 Years
Not Enrolling
Male
Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Pharmacokinetic profile

Outcome Time Frame:

after 1 month

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

15524

NCT ID:

NCT01322438

Start Date:

March 2011

Completion Date:

May 2011

Related Keywords:

  • Neoplasms
  • healthy volunteers
  • rifampin
  • pharmacokinetics
  • single dose
  • Neoplasms

Name

Location

Austin, Texas  78705