Trial Condition(s):
Pharmacokinetics
Effect of Ketoconazole on Regorafenib (BAY73-4506) pharmacokinetics
Bayer Identifier:
12435
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations ProMedica Clincal Research Center Brighton, United States, 02135 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
1
Primary Outcome
- Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole.Timeframe: 1 month
- Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazoleTimeframe: 1 month
Secondary Outcome
- Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.Timeframe: 1 month
- Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.Timeframe: 1 month
- Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole.Timeframe: 1 month
Additional Information
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