Status:
COMPLETED
The Effect of Food (High Fat and Low Fat Breakfast) on the Pharmacokinetics of Regorafenib
Lead Sponsor:
Bayer
Conditions:
Dietary Fats
Pharmacokinetics
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Healthy male subject
- Age: 18 to 45 years (inclusive) at the first Screening examination
- BMI: between 18 and 32 kg / m²
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01002378
Start Date
October 1 2009
End Date
February 1 2010
Last Update
May 23 2013
Active Locations (1)
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1
Brighton, Massachusetts, United States, 02135