The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649. The pharmacodynamic activity of PF-06743649 will also be assessed. The effect of food on PK of PF-06743649 will also be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
40
40 mg tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
Placebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
To be decided dose, tablet once daily dosing for 14 days
New Haven Clinical Research Unit
New Haven, Connecticut, United States
Maximum Observed Plasma Concentration (Cmax)
Time frame: up to 14 days
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
Time frame: up to 14 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: up to 14 days
Plasma Decay Half-Life (t1/2)
Time frame: up to 14 days
Amount of drug recovered unchanged in urine during the dosing interval (Aetau)
Time frame: up to 14 days
Percent of dose recovered unchanged in urine during the dosing interval(Aetau%)
Time frame: up to 14 days
Renal clearance (CLr)
Time frame: up to 14 days
Change from baseline in serum uric acid level
Time frame: up to 14 days
Change from baseline in serum levels of xanthine and hypoxanthine
Time frame: up to 14 days
Urinary uric acid levels
Time frame: up to 14 days
Urinary xanthine levels
Time frame: up to 14 days
Urinary hypoxanthine levels
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Placebo tablet once daily dosing for 14 days
To be decided dose, tablet, one time once with a meal and once without a meal, followed by once daily dosing for 14 days
Placebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
To be decided dose, tablet, one time without a meal, followed by once daily dosing for 14 days
Placebo tablet one time once without a meal, followed by once daily dosing for 14 days
Tablet, to be decided dose, once daily, 14 days
Tablet, once daily, 14 days
Time frame: up to 14 days