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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
24
A single dose of regorafenib will be administered immediately following a high fat breakfast
A single dose of regorafenib will be administered immediately following a low fat breakfast
A single dose of regorafenib will be administered following an overnight fast
Unnamed facility
Brighton, Massachusetts, United States
Primary PK parameters: AUC, Cmax of BAY 73-4506
Time frame: Samples up to 336 hours post dose
Sec. PK Parameters: tmax and t1/2 of BAY73-4506
Time frame: Samples up to 336 hours post dose
AUC, Cmax, tmax and t1/2 of Metabolites
Time frame: Samples up to 336 hours post dose
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