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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: PF-05175157; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • South Miami, Florida, United States, 33143
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 100 mg PF-05175157; The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.	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.
Experimental: 250 mg PF-05175157; The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.	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.
Experimental: 600 mg PF-05175157; The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.	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.
Placebo Comparator: Placebo; The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.	Drug: Placebo; One single oral dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Modulation of carbohydrate and lipid metabolism	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax of PF-05175157 after single oral doses	24 hours
Tmax of PF-05175157 after single oral doses	24 hours
Area under the curve (AUC) of PF-05175157 after single oral doses	24 hours

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 17, 2012
• First Submitted That Met QC Criteria: February 17, 2012
• First Posted (Estimate): February 23, 2012

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: July 6, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Phase 1; Pharmacodynamics; Single Doses
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: B1731013