A Study To Evaluate PF-05175157 In Healthy Volunteers - Full Text View

Purpose

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

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: PF-05175157 Drug: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Official Title:	Phase 1 Study To Evaluate The Effect Of Single Doses Of Pf-05175157 On Pharmacodynamic And Metabolic Parameters In Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Pharmacokinetics: 0.5, 1, 1.5, 2.5, 6.5, 10.5, 24 hrs after dosing, parameters: Cmax, Tmax and Area under the Curve (AUC) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	July 2011
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: PF-05175157 One single dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.
Placebo Comparator: Placebo Subjects will receive one dose of placebo. The sequence of receiving placebo or 600 mg PF-05175157 will be randomized.	Drug: Placebo One single dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433380

Locations

United States, Louisiana
Pfizer Investigational Site
Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01433380 History of Changes
Other Study ID Numbers:	B1731004
Study First Received:	August 23, 2011
Last Updated:	May 16, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Phase 1
Single Doses
Pharmacodynamics
Healthy Volunteers

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013