A Study 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 the safety, tolerability and pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers.

Official Title
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A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-05175157 After Administration Of Single Escalating Oral Doses Under Fasted And Fed Conditions In Healthy Volunteers

Conditions
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Diabetes Mellitus, Type 2

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 45 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 measurements, 12-lead ECG and clinical laboratory tests. In addition, subjects must have normal chest x-ray, normal pulmonary function tests and normal ophthalmological examination. Body Mass Index (BMI) of 17.5 to 29.5 kg/m2; and a total body weight > 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). 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 0. Active ocular disease including infection, glaucoma, seasonal allergies, dry-eye symptoms or retinal/optic nerve disease. Evidence or history of 'dry eye-syndrome', Meibomian gland disease, ocular inflammation (eg, uveitis, iritis), chronic blepharitis, any eye surgery including Lasik, any mechanical injury or chemical exposure to the ocular surface, use of ocular lubricants, or use of contact lenses.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: 10 mg PF-05175157 or Placebo<br>Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. | Drug: PF-05175157 or Placebo<br>* One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.<br>|
| Experimental: 30 mg PF-05175157 or Placebo<br>Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. | Drug: PF-05175157 or Placebo<br>* One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.<br>|
| Experimental: 100 mg PF-05175157 or Placebo<br>Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. | Drug: PF-05175157 or Placebo<br>* One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.<br>|
| Experimental: 300 mg PF-05175157 or Placebo<br>Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. | Drug: PF-05175157 or Placebo<br>* One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.<br>|
| Experimental: 600 mg PF-05175157 or Placebo<br>Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. | Drug: PF-05175157 or Placebo<br>* One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.<br>|
| Experimental: 800 mg PF-05175157 or Placebo<br>Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. | Drug: PF-05175157 or Placebo<br>* One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.<br>|
| Experimental: xxx mg PF-05175157 or Placebo<br>Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order. | Drug: PF-05175157 or Placebo<br>* One dose of PF-05175157 will be administered as a powder-in-capsule immediately after breakfast; correspondingly, one dose of a matched powder-in-capsule placebo will be administered immediately after breakfast.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of escalating single doses of PF-05175157 in healthy subjects |  | 5 months | 
| Single dose pharmacokinetics of PF-05175157 |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory pharmacodynamic biomarkers |  | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single Ascending Dose, Phase 1, Safety and Tolerability, PK, Healthy Subjects