Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics
Phase 1
Completed
- Conditions
- Pharmacokinetics
- Interventions
- Registration Number
- NCT01318265
- Lead Sponsor
- Bayer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- Healthy male subjects between 18 and 45 years of age, inclusive
- BMI between 18 and 32 kg/m2 inclusive
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm1 Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole -
- Primary Outcome Measures
Name Time Method Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole 1 month Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole. 1 month
- Secondary Outcome Measures
Name Time Method Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole. 1 month Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole. 1 month Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole. 1 month