The study is designed to understand the blood concetration of PF-06412562 and its metabolite, PF-06663872, following a single oral dose of a modified release formulation. The study will include two doses of the PF-06412562 modified release formulation to understand the proportionality. Effect of food on absorption of PF-06412562 from the modified release formulation will also be investigated in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast
Two 15 mg PF-06412562 modified release tablets administered after an overnight fast
Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast
Pfizer Clinical Research Unit
Brussels, Belgium
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0-2 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0-2 days
Time after dose and before the first plasma concentration (Tlag)
Time frame: 0-2
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0 - t) plus AUC (t - inf).
Time frame: 0- 2 days
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Time frame: 0-2 days
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: 0-2 days
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a single immediate release tablet of 10 mg PF-06412562 after an overnight fast