This study will evaluate the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation in 24 healthy volunteers when taken after eating a high fat meal (the effect of food). This will be compared to the drug behavior and safety of a single dose of the 11 milligram tofacitinib (CP-690,550) modified-release formulation when taken after a 10 hour fast.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
A single dose of tofacitinib modified release 11 mg tablet after receiving the standard FDA high fat/high calorie meal.
tofacitinib modified release (MR) 11 mg tablet after a 10 hour overnight fast.
Glendale Adventist Medical Center
Glendale, California, United States
Area under the curve from time zero to infinity
Area under the curve from time zero to infinity
Time frame: 48 hours post dose
Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration
Area under the plasma concentration-time profile from time zero to time of the last quantifiable concentration
Time frame: 48 hours post dose
Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration (Cmax)
Time frame: 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time to peak concentration
Time frame: 48 hours post dose
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 48 hours post dose
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