Trial Condition(s):
Dietary Fats, Pharmacokinetics
The effect of food (high fat and low fat breakfast) on the pharmacokinetics of regorafenib
Trial Purpose
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.
Inclusion Criteria
- Healthy male subject - Age: 18 to 45 years (inclusive) at the first Screening examination - BMI: between 18 and 32 kg / m²
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
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, 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
Primary Outcome
- Primary PK parameters: AUC, Cmax of BAY 73-4506Timeframe: Samples up to 336 hours post dose
Secondary Outcome
- Sec. PK Parameters: tmax and t1/2 of BAY73-4506Timeframe: Samples up to 336 hours post dose
- AUC, Cmax, tmax and t1/2 of MetabolitesTimeframe: Samples up to 336 hours post dose
Additional Information
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