Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics
NCT ID: NCT01318265
Last Updated: 2014-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2011-03-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
NONE
Study Groups
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Arm1
Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole
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.
Interventions
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Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole
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 Criteria
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Inclusion Criteria
* BMI between 18 and 32 kg/m2 inclusive
Exclusion Criteria
* 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
18 Years
45 Years
MALE
Yes
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Brighton, Massachusetts, United States
Countries
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Other Identifiers
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12435
Identifier Type: -
Identifier Source: org_study_id
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