Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.

Recruitment & Eligibility

Inclusion Criteria

Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and cardiac evaluation (including ECG).
BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria

Evidence or history of clinically significant hematological, renal, endocrine (including diabetes), pulmonary, gastrointestinal, cardiovascular (including hypertension and congestive heart failure), hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.

Participants with any of the following acute or chronic infections or infection history:

Any infection requiring treatment within 2 weeks prior to the dosing visit.
Any infection requiring hospitalization or parenteral antimicrobial therapy within 60 days of the first dose of study intervention.
Any infection judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months of the first dose of study intervention.
Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.
History of recurrent (more than one episode of) localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster.

Study & Design

Arm && Interventions

Group	Intervention	Description
Treatment Sequence 1	PF-06651600	PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2), and followed by Capsules (fed, Period 3).
Treatment Sequence 3	PF-06651600	PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2).
Treatment Sequence 2	PF-06651600	PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2), and followed by Capsules (fed, Period 3).
Treatment Sequence 4	PF-06651600	PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2).

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600	Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Maximum plasma PF-06651600 concentration (C max)	Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.

Secondary Outcome Measures

Name	Time	Method
Single dose time to reach maximum observed plasma concentration (Tmax) of PF-06651600	Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Single dose Area under the Curve from Time Zero to Last quantifiable concentration [AUC last) of PF-06651600	Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Single dose plasma decay half-life (t 1/2) of PF-06651600	Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Single dose Apparent Oral Clearance (CL/F) of PF-06651600	Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Single dose Apparent Volume of Distribution (Vz/F) of PF-06651600	Day 1 pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose.
Frequency of abnormal safety laboratory tests	Baseline up to day 9
Frequency of Adverse Events	Baseline up to day 35

Recruitment & Eligibility