Trial Condition(s):
Dietary Fats, Pharmacokinetics
The effect of food (high fat and low fat breakfast) on the pharmacokinetics of regorafenib
Bayer Identifier:
14656
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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 | |
|---|---|
Locations ProMedica Clincal Research Center Brighton, United States, 02135 | 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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