A Study To Evaluate PF-05175157 In Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01433380
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : May 18, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: PF-05175157 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : July 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Changes in carbohydrate and lipid metabolism [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01433380

United States, Louisiana
Pfizer Investigational Site
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT01433380     History of Changes
Other Study ID Numbers: B1731004
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: May 18, 2012
Last Verified: May 2012

Keywords provided by Pfizer:
Phase 1
Single Doses
Healthy Volunteers

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases