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

Study Overview
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Brief Summary
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The study will be conducted as a Phase 1, open-label, single-dose, randomized, 2- or 3 period, cross over design in a single cohort.

Official Title
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A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSS-OVER, SINGLE-DOSE STUDY TO EVALUATE THE BIOEQUIVALENCE OF CANDIDATE CAPSULE FORMULATIONS OF PF-06651600 TO TABLETS AND ESTIMATE THE EFFECT OF HIGH-FAT MEAL ON BIOAVAILABILITY IN HEALTHY PARTICIPANTS

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: PF-06651600


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence 1<br>PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2), and followed by Capsules (fed, Period 3). | Drug: PF-06651600<br>* PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.<br>|
| Experimental: Treatment Sequence 2<br>PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2), and followed by Capsules (fed, Period 3). | Drug: PF-06651600<br>* PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.<br>|
| Experimental: Treatment Sequence 3<br>PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2). | Drug: PF-06651600<br>* PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.<br>|
| Experimental: Treatment Sequence 4<br>PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2). | Drug: PF-06651600<br>* PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |