The Effect of Food (High Fat and Low Fat Breakfast) on the Pharmacokinetics of Regorafenib
Phase 1
Completed
- Conditions
- Dietary FatsPharmacokinetics
- Interventions
- Registration Number
- NCT01002378
- Lead Sponsor
- Bayer
- Brief Summary
An open label, three way crossover study to determine the effect of a high fat breakfast or a low fat breakfast on the pharmacokinetics of a single dose of regorafenib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
- Healthy male subject
- Age: 18 to 45 years (inclusive) at the first Screening examination
- BMI: between 18 and 32 kg / m²
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Exclusion Criteria
- Regular use of medicines at the time of Screening, including prescription medications, herbal supplements and high dose vitamins
- Sitting systolic BP > 140 mmHg or Diastolic BP > 90 or < 60 mmHg
- History of hypersensitivity or allergy
- History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 1 Regorafenib (Stivarga, BAY73-4506) - Arm 2 Regorafenib (Stivarga, BAY73-4506) - Arm 3 Regorafenib (Stivarga, BAY73-4506) -
- Primary Outcome Measures
Name Time Method Primary PK parameters: AUC, Cmax of BAY 73-4506 Samples up to 336 hours post dose
- Secondary Outcome Measures
Name Time Method Sec. PK Parameters: tmax and t1/2 of BAY73-4506 Samples up to 336 hours post dose AUC, Cmax, tmax and t1/2 of Metabolites Samples up to 336 hours post dose