A Healthy Volunteer Study To Assess Relative Bioavailability Of Powder-In-Capsule And A Tablet Formulation And The Effect Of Food On The Pharmacokinetics Of The Tablet Formulation

Study Overview
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Brief Summary
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The purpose of this study in healthy volunteers is to assess the relative bioavailability of PF-05175157 as powder-in-capsule and a tablet formulation and the effect of food on the pharmacokinetics of the tablet formulation.

Official Title
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A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Relative Bioavailability Of Powder-In-Capsule And A Tablet Formulation Of Pf-05175157 And The Effect Of Food On The Pharmacokinetics Of The Tablet Formulation In Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-05175157
* Drug: PF-05175157
* Drug: PF-05175157
* Drug: PF-05175157


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive Women must be of non childbearing potential Body Mass Index (BMI) of 25 to 35 kg/m2; and a total body weight >50 kg (110 lbs) Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening. Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms, optic nerve disease or retinal disease. History of habitual smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day 0

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: PF-05175157 PIC in fed state<br>200 mg single dose of PF-05175157 administered as PIC in the fed state (following a standard high fat meal). | Drug: PF-05175157<br>* Single 200 mg dose of PF-05175157 administered as powder in capsule (2x100 mg)<br>|
| Experimental: PF-05175157 tablet in fed state<br>200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal). | Drug: PF-05175157<br>* Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)<br>|
| Experimental: PF-05175157 tablet in fed state (repeat)<br>200 mg single dose of PF-05175157 administered as tablet formulation in the fed state (following a standard high fat meal). | Drug: PF-05175157<br>* Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)<br>|
| Experimental: PF-05175157 tablet in fasted state<br>200 mg single dose of PF-05175157 administered as tablet formulation in the fasted state (following at least a 10 hour fast). | Drug: PF-05175157<br>* Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) |  | 0 to 72 H after dose | 
| Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) |  | 0 to 72 H after dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |  | 0 to 72 H after dose | 
| Time at which maximum plasma concentration is observed (Tmax) |  | 0 to 72 H after dose | 
| Plasma Decay Half-Life (t1/2) |  | 0 to 72 H after dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single dose, Relative Bioavailability, Food effect, Healthy subjects, Diabetes Mellitus Type 2