Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics

A Phase I, Non-Randomized, Open Label Study to Determine the Effetc of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of Regorafenib (BAY73-4506) in Healthy Volunteers

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