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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: PF-05175157; Drug: Placebo

• Registration Number: NCT01537497
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-23
• Study Start: 2012-03
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-06
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Modulation of carbohydrate and lipid metabolism	24 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 South Miami, Florida, United States