A Study Of PF-05175157 In Healthy Volunteers

Phase 1

Completed

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

• Registration Number: NCT01274663
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-10
• Study First Posted: 2011-01-11
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-07
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 0.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
300 mg PF-05175157 or Placebo	PF-05175157 or Placebo	Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
600 mg PF-05175157 or Placebo	PF-05175157 or Placebo	Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
xxx mg PF-05175157 or Placebo	PF-05175157 or Placebo	Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
30 mg PF-05175157 or Placebo	PF-05175157 or Placebo	Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
10 mg PF-05175157 or Placebo	PF-05175157 or Placebo	Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
100 mg PF-05175157 or Placebo	PF-05175157 or Placebo	Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
800 mg PF-05175157 or Placebo	PF-05175157 or Placebo	Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of escalating single doses of PF-05175157 in healthy subjects	5 months
Single dose pharmacokinetics of PF-05175157	5 months

Secondary Outcome Measures

Name	Time	Method
Exploratory pharmacodynamic biomarkers	5 months

Trial Locations

Locations (1)

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