A Study To Evaluate PF-05175157 In Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-05-31

Brief Summary

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The primary purpose of this study is to evaluate the pharmacodynamics of single oral doses of PF-05175157 in healthy volunteers

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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600 mg PF-05175157

Subjects will receive one dose of PF-05175157. The sequence of receiving 600 mg PF-05175157 or placebo will be randomized.

Group Type EXPERIMENTAL

PF-05175157

Intervention Type DRUG

One single dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.

Placebo

Subjects will receive one dose of placebo. The sequence of receiving placebo or 600 mg PF-05175157 will be randomized.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One single dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.

Interventions

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PF-05175157

One single dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.

Intervention Type DRUG

Placebo

One single dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.

Intervention Type DRUG

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 examination.
* Body Mass Index of 20.0 35.0 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, but excluding untreated, asymptomatic, 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 0.
* Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes