Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Ketoconazole

Criteria

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