A Study To Evaluate The Effects Of PF-05175157 In Healthy Volunteers

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate pharmacodynamics of single oral doses of PF-05175157 in a dose-dependent fashion in healthy volunteers

Official Title
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Phase 1 Four-Arm Parallel Group, Placebo-Controlled Study To Evaluate The Effects Of Single Doses Of PF- 05175157 At Three Dose Levels On Pharmacodynamic And Metabolic Parameters In Healthy Volunteers

Conditions
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Diabetes Mellitus, Type 2

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


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. 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 and clinical laboratory tests. In addition, subjects must have normal pulmonary function tests and normal ocular findings. Women must be of non-childbearing potential. Body Mass Index (BMI) of 19.5 35.5 kg/m2, and a total body weight of > 50 kg (110 lbs). Exclusion Criteria: Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and seasonal allergies at time of dosing). Evidence or history of any chronic ongoing or current pulmonary disease. History of 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 -7. Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 100 mg PF-05175157<br>The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. | Drug: PF-05175157<br>* One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.<br>|
| Experimental: 250 mg PF-05175157<br>The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. | Drug: PF-05175157<br>* One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.<br>|
| Experimental: 600 mg PF-05175157<br>The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. | Drug: PF-05175157<br>* One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.<br>|
| Placebo Comparator: Placebo<br>The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized. | Drug: Placebo<br>* One single oral dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modulation of carbohydrate and lipid metabolism |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of PF-05175157 after single oral doses |  | 24 hours | 
| Tmax of PF-05175157 after single oral doses |  | 24 hours | 
| Area under the curve (AUC) of PF-05175157 after single oral doses |  | 24 hours | 

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