A Study Of Three PF-05190457 Formulations In Healthy Volunteers

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the plasma drug concentrations of three formulations of PF-05190457 after administration of single doses to healthy volunteers.

Official Title
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A Phase I, Cross-Over, Single Dose, Double-Blind Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-05190457 In Healthy Adult Volunteers

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: PF-05190457
* Drug: PF-05190457
* Drug: PF-05190457
* Drug: PF-05190457
* Drug: PF-05190457
* Drug: PF-05190457
* Drug: PF-05190457
* Drug: PF-05190457


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females of non-childbearing potential between ages of 21 and 55 years, BMI of 17.5 to 30.5 kg/m^2, and weight above 50 kg. Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100 mg PF-05190457<br>Three fasted treatments and fed with the short-duration osmotic capsule | Drug: PF-05190457<br>* 100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state<br>Drug: PF-05190457<br>* 100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state<br>Drug: PF-05190457<br>* 100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state<br>Drug: PF-05190457<br>* 100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state<br>|
| Experimental: 100 mg PF - 05190457<br>Three fasted treatments and fed with the long-duration osmotic capsule | Drug: PF-05190457<br>* 100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state<br>Drug: PF-05190457<br>* 100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state<br>Drug: PF-05190457<br>* 100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state<br>Drug: PF-05190457<br>* 100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fed state<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between formulations as data permit. |  | 0 - 48 hours post dose | 
| The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between formulations as data permit. |  | 0 - 48 hours post dose | 
| The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Time of Maximum concentration (Tmax) as data permit. |  | 0 - 48 hours post dose | 
| The single dose pharmacokinetics of PF-05190457 in three formulations will be described by estimating parameter of Elimination of half-life (t ½ ) as data permit. |  | 0 - 48 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Area Under the Curve (AUC) and its ratio between fed states as data permit. |  | 0 - 48 hours post dose | 
| The ratio of fasted to fed single dose pharmacokinetics of PF-05190457 in two test formulations will be described by estimating parameters of Maximum Concentration (Cmax) and its ratio between fed states as data permit. |  | 0 - 48 hours post dose | 
| Changes in plasma glucose and insulin due to single doses of three formulations of PF-05190457 will be estimated. |  | 0 - 24 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Single Doses, Biocomparison, Pharmacokinetics, Healthy Volunteers