Trial Condition(s):
The effect of food (high fat and low fat breakfast) on the pharmacokinetics of regorafenib
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.
- Healthy male subject - Age: 18 to 45 years (inclusive) at the first Screening examination - BMI: between 18 and 32 kg / m²
- 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
Locations | Status | ||
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Locations ProMedica Clincal Research Center Brighton, United States, 02135 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
A Phase I, Randomized, Open Label, 3-Way Cross-Over Study to Determine the Effect of a High-Fat Breakfast, a Low-Fat Breakfast and Fasting State on the Pharmacokinetics of a Single Oral Dose of 160 mg Regorafenib (BAY73-4506) in Healthy Volunteers
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Screening
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
3