A Study To Compare The Pharmacokinetics Of Different Formulations Of PF-04937319 In Healthy Subjects

Study Overview
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Brief Summary
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This study is designed to compare the pharmacokinetics of three different formulations of Pf-04937319

Official Title
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A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-04937319 In Overweight And Obese Otherwise Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Pf-04937319
* Drug: Pf-04937319
* Drug: Pf-04937319


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests. Subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28-days after the last dose of treatment. Body Mass Index (BMI) of 23 to 33 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 disease (excluding untreated seasonal allergies). Any condition possibly affecting drug absorption (eg, gastrectomy). A positive urine drug screen.

Ages Eligible for Study
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Minimum Age: 21 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pf-04937319|Formulation A) Pf-04937319 50 mg - administered as tablet|
|Drug: Pf-04937319|Formulation B) Pf-04937319 50 mg - administered as capsule|
|Drug: Pf-04937319|Formulation C) Pf-04937319 50 mg - administered as capsule|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pf-04937319: Maximum plasma concentration (Cmax) |  | 0 - 96 hours post dose | 
| Pf-04937319: Time for Cmax (Tmax) |  | 0 - 96 hours post dose | 
| Pf-04937319: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast) |  | 0 - 96 hours post dose | 
| Pf-04937319: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf) |  | 0 - 96 hours post dose | 
| Pf-04937319: terminal half-life (T1/2) |  | 0 - 96 hours post dose | 
| PF-06455349: Maximum Observed Plasma Concentration (Cmax) |  | 0 - 96 hours post dose | 
| PF-06455349: Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 0 - 96 hours post dose | 
| PF-06455349: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |  | 0 - 96 hours post dose | 
| PF-06455349: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] |  | 0 - 96 hours post dose | 
| PF-06455349: Plasma Decay Half-Life (t1/2) |  | 0 - 96 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, relative bioavailability, formulation comparison