Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics

Bayer

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01318265

12435

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy 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 design

24 participants in 1 patient group

Arm1

Experimental group

Treatment:

Drug: Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole