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:

NCT01002378

EudraCT Number:

Not Available

Study Completed

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
24
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

ProMedica Clincal Research Center

Brighton, United States, 02135

Status
Completed
 

Trial Design