A Study To Evaluate PF-05175157 In Healthy Volunteers

Phase 1

Completed

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

• Registration Number: NCT01433380
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-09-12
• Study First Posted: 2011-09-13
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-16
• Last Update Posted: 2012-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
600 mg PF-05175157	PF-05175157	Subjects will receive one dose of PF-05175157. The sequence of receiving 600 mg PF-05175157 or placebo will be randomized.
Placebo	Placebo	Subjects will receive one dose of placebo. The sequence of receiving placebo or 600 mg PF-05175157 will be randomized.

Primary Outcome Measures

Name	Time	Method
Changes in carbohydrate and lipid metabolism	24 hours

Secondary Outcome Measures

Name	Time	Method
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)	24 hours

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Baton Rouge, Louisiana, United States