Neoplasms
Conditions
Keywords
healthy volunteers, rifampin, pharmacokinetics, single dose
Brief summary
The purpose of this study is to see if giving rifampin, a marketed antibiotic, changes how your body absorbs and distributes BAY73-4506.
Interventions
DRUGRegorafenib (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.
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile | after 1 month |
| Proportion of subjects with adverse event collection | after 35 days |
Countries
United States
Outcome results
None listed