Trial Condition(s):

Pharmacokinetics

Effect of Ketoconazole on Regorafenib (BAY73-4506) pharmacokinetics

Bayer Identifier:

12435

ClinicalTrials.gov Identifier:

NCT01318265

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.

Inclusion Criteria
- Healthy male subjects between 18 and 45 years of age, inclusive
 - BMI between 18 and 32 kg/m2 inclusive
Exclusion Criteria
- Subjects with evidence of disease, conditions affecting drug absorption or metabolism
 - Treatment with other investigational drug within 30 days
 - History of regular alcohol or recreational drug consumption
 - Use of prescription drugs within 14 days
 - Use of nonprescription drugs and dietary supplement within 7 days
 - Blood donation within 30 days

Trial Summary

Enrollment Goal
24
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

ProMedica Clincal Research Center

Brighton, United States, 02135

Status
Completed
 

Trial Design