This study is to investigate the safety, tolerability and pharmacokinetics of single ascending oral doses of PF-04991532 in Japanese healthy subjects. The secondary objective is to investigate the pharmacokinetics and safety of single ascending oral doses of PF-04991532 in Western healthy subjects and to compare the pharmacokinetics between Japanese and Western healthy subjects.
Safety/Tolerability and Pharmacokinetics
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
22
Single dose administration of PF-04991532 (100 mg, 300 mg and 750 mg) in tablet formulation under fasted condition.
Single dose administration of matching placebo in tablet formulation at the fasted state
Single dose administration of PF-04991532 (300 mg and 750 mg) in tablet formulation under fasted condition.
Pfizer Investigational Site
New Haven, Connecticut, United States
Maximum Plasma Concentration (Cmax)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours post dose
Time for Cmax (Tmax)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
Area under the plasma concentration-time profile from time zero to 24 hours (AUC0-24)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10,12 and 16, 24, 36 and 48 hours
Total amount of unchanged drug excreted in the urine over 24 hours, expressed as percent of dose (Ae24%)
Time frame: Urine collection from 0 to 24 hours post dose
Renal clearance (CLr)
Time frame: Urine collection from 0 to 24 hours post dose
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