check_circleStudy Completed
Dietary Fats, Pharmacokinetics
Bayer Identifier:
14656
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
24Trial Dates
October 2009 - February 2010Phase
Phase 1Could I Receive a placebo
NoProducts
Stivarga (Regorafenib, BAY73-4506)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | ProMedica Clincal Research Center | Brighton, 02135, United States |
Primary Outcome
- Primary PK parameters: AUC, Cmax of BAY 73-4506date_rangeTime Frame:Samples up to 336 hours post doseenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Sec. PK Parameters: tmax and t1/2 of BAY73-4506date_rangeTime Frame:Samples up to 336 hours post doseenhanced_encryptionnoSafety Issue:
- AUC, Cmax, tmax and t1/2 of Metabolitesdate_rangeTime Frame:Samples up to 336 hours post doseenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
ScreeningAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
3