Bioavailability Study Of PF-06651600 In Healthy Subjects

Study Overview
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Brief Summary
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PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral solution formulation under fasting conditions and the effect of a high fat meal on the bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed under fasting and fed conditions.

Official Title
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A Phase 1, Open Label, Single-dose 3-way Crossover Study To Evaluate The Relative Bioavailability Of A Solid Dose Formulation Of Pf-06651600 Under Fasting Conditions And The Effect Of A High Fat Meal On The Bioavailability Of The Solid Dosage Formulation Of Pf-06651600 In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-06651600


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential. BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). Prior history of chicken pox. Evidence of personally signed and dated informed consent document. Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males. Screening blood pressure >140/90 mm Hg. Screening laboratory abnormalities as defined by the protocol. Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.

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: Cohort 1: PF-06651600<br>Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. | Drug: PF-06651600<br>* PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.<br>|
| Experimental: Cohort 2: PF-06651600<br>Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. | Drug: PF-06651600<br>* PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.<br>|
| Experimental: Cohort 3: PF-06651600<br>Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. | Drug: PF-06651600<br>* PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.<br>|
| Experimental: Cohort 4: PF-06651600<br>Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. | Drug: PF-06651600<br>* PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.<br>|
| Experimental: Cohort 5: PF-06651600<br>Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. | Drug: PF-06651600<br>* PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.<br>|
| Experimental: Cohort 6: PF-06651600<br>Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. | Drug: PF-06651600<br>* PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600 | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | 
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06651600 | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | 
| Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600 | Time to Reach Maximum Observed Plasma Concentration (Cmax) | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Decay Half Life (t1/2) for PF-06651600 | Plasma Decay Half-Life (t1/2) | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | 
| Time to Reach Maximum Concentration (Tmax) for PF-06651600 | Time to Reach Maximum Concentration (Tmax) | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Disease