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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01537497

First received: February 17, 2012

Last updated: July 6, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 17, 2012

Last Updated Date

July 6, 2012

Start Date ^ICMJE

March 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Modulation of carbohydrate and lipid metabolism [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01537497 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Cmax of PF-05175157 after single oral doses [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Tmax of PF-05175157 after single oral doses [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Area under the curve (AUC) of PF-05175157 after single oral doses [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 100 mg PF-05175157
The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Intervention: Drug: PF-05175157
Experimental: 250 mg PF-05175157
The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Intervention: Drug: PF-05175157
Experimental: 600 mg PF-05175157
The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Intervention: Drug: PF-05175157
Placebo Comparator: Placebo
The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2012

Primary Completion Date

May 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01537497

Other Study ID Numbers ^ICMJE

B1731013

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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