The purpose of this study is to evaluate the tolerability, safety and pharmacokinetics of PF-06650833 orally administered as modified release tablets in healthy Japanese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
10
P-one Clinic, Keikokai Medical Corporation
Hachioji-shi, Tokyo, Japan
Number of participants experiencing an AE/SAE
Time frame: Day 18
Maximum plasma concentration (Cmax)
Time frame: Day 1 and Day 10
Area under the plasma concentration time curve for dosing interval (AUCtau)
Time frame: Day 1 and Day 10
Time to peak concentration
Time frame: Day 1 and Day 10
Clearance
Time frame: Day 10
Volume of distribution
Time frame: Day 10
Observed exposure accumulation ratio for AUCtau
Time frame: Day 10
Observed exposure accumulation ratio for Cmax
Time frame: Day 10
Minimum plasma concentration (Cmin)
Time frame: Days 2, 4, 7 and 10
Fluctuation ratio (Cmax:Cmin)
Time frame: Day 10
Mean residence time
Time frame: Day 10
change from baseline in vital signs
Time frame: Day 18
change form baseline in electrocardiogram (ECG) parameters
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Time frame: Day 18
Incidence of treatment emergent clinical laboratory abnormalities
Time frame: Day 18