This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner, beginning with low doses not expected to have significant biological effects and proceeding to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored may be limited by tolerability, and will not exceed levels previously shown to be tolerable in animals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
27
Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the first cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)
Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the second cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)
Oral; sequential single dose escalation; three fourteen-day treatment periods per subject in the third cohort; randomized assignment to treatment (placebo or PF-04629991)
Pfizer Investigational Site
Brussels, Belgium
Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve
Time frame: 2 weeks
Safety/Tolerability e.g., reported adverse events and safety laboratory studies
Time frame: 2 weeks
Pharmacodynamics e.g., changes in a peripheral blood biomarker
Time frame: 2 weeks
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