A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-05175157 After Administration Of Single Escalating Oral Doses Under Fasted And Fed Conditions In Healthy Volunteers

Pfizer1 site in 1 country63 target enrollmentNovember 2010

ConditionsDiabetes Mellitus, Type 2

InterventionsPF-05175157 or Placebo

DrugsPF-05175157 or Placebo

Overview

Phase: Phase 1
Intervention: PF-05175157 or Placebo
Conditions: Diabetes Mellitus, Type 2
Sponsor: Pfizer
Enrollment: 63
Locations: 1
Primary Endpoint: Safety and tolerability of escalating single doses of PF-05175157 in healthy subjects
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single oral doses of PF-05175157 in healthy volunteers.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

May 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 45 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 measurements, 12-lead ECG and clinical laboratory tests.
•In addition, subjects must have normal chest x-ray, normal pulmonary function tests and normal ophthalmological examination.
•Body Mass Index (BMI) of 17.5 to 29.5 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).
•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
•Active ocular disease including infection, glaucoma, seasonal allergies, dry-eye symptoms or retinal/optic nerve disease.
•Evidence or history of 'dry eye-syndrome', Meibomian gland disease, ocular inflammation (eg, uveitis, iritis), chronic blepharitis, any eye surgery including Lasik, any mechanical injury or chemical exposure to the ocular surface, use of ocular lubricants, or use of contact lenses.