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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-05175157

Placebo

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring Phase 1, Single Doses, Pharmacodynamics, Healthy Volunteers

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

100 mg PF-05175157

250 mg PF-05175157

600 mg PF-05175157

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

Modulation of carbohydrate and lipid metabolism

Secondary Outcome Measures

Cmax of PF-05175157 after single oral doses

Tmax of PF-05175157 after single oral doses

Area under the curve (AUC) of PF-05175157 after single oral doses

Full Information

NCT ID

NCT01537497

First Posted

February 17, 2012

Last Updated

July 6, 2012

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01537497

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Phase 1, Single Doses, Pharmacodynamics, Healthy Volunteers

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

100 mg PF-05175157

Arm Type

Experimental

Arm Description

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

Arm Title

250 mg PF-05175157

Arm Type

Experimental

Arm Description

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

Arm Title

600 mg PF-05175157

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

PF-05175157

Intervention Description

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

Intervention Name(s)

PF-05175157

Intervention Description

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

Intervention Name(s)

PF-05175157

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Modulation of carbohydrate and lipid metabolism

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Cmax of PF-05175157 after single oral doses

Time Frame

24 hours

Title

Tmax of PF-05175157 after single oral doses

Time Frame

24 hours

Title

Area under the curve (AUC) of PF-05175157 after single oral doses

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

South Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

12. IPD Sharing Statement

Links:

URL

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

Description

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

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