The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.
Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.
Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.
Pfizer Investigational Site
Brussels, Belgium
Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index
Time frame: days 1-15
Safety of subjects following multiple dosing of PF-04531083 (adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood and urine safety tests)
Time frame: days 1-15
pharmacokinetics of alternative formulations
Time frame: days 1-15
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A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.