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

NCT ID: NCT01537497

Last Updated: 2012-07-10

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

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-05-31

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

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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Phase 1 Single Doses Pharmacodynamics Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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100 mg PF-05175157

The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Group Type EXPERIMENTAL

PF-05175157

Intervention Type DRUG

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

250 mg PF-05175157

The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Group Type EXPERIMENTAL

PF-05175157

Intervention Type DRUG

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

600 mg PF-05175157

The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Group Type EXPERIMENTAL

PF-05175157

Intervention Type DRUG

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

Placebo

The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Intervention Type DRUG

PF-05175157

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

Intervention Type DRUG

PF-05175157

One single oral 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 oral 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 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

South Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1731013&StudyName=A%20Study%20To%20Evaluate%20The%20Effects%20Of%20PF-05175157%20In%20Healthy%20Volunteers

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1731013

Identifier Type: -

Identifier Source: org_study_id