Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics

Bayer24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Pharmacokinetics

Interventions

Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazoleDRUG

Treatment 1: A single 160 mg dose of BAY73-4506. Treatment 2: Ketoconazole 400 mg once daily from Day -4 to Day 3. A single 160 mg dose of BAY73-4506 on Day 1.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Brighton, Massachusetts, United States

Outcomes

Primary Outcomes

Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole.

Time frame: 1 month

Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole

Time frame: 1 month

Secondary Outcomes

Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.

Time frame: 1 month

Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.

Time frame: 1 month

Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole.

Time frame: 1 month

Data from ClinicalTrials.gov

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