A Study Of PF-05175157 In Healthy Volunteers

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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 63
• 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 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 mg PF-05175157 or Placebo; Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.	Drug: PF-05175157 or Placebo; One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.; Drug: PF-05175157 or Placebo; One dose of PF-05175157 will be administered as a powder-in-capsule immediately after breakfast; correspondingly, one dose of a matched powder-in-capsule placebo will be administered immediately after breakfast.
Experimental: 30 mg PF-05175157 or Placebo; Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.	Drug: PF-05175157 or Placebo; One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.; Drug: PF-05175157 or Placebo; One dose of PF-05175157 will be administered as a powder-in-capsule immediately after breakfast; correspondingly, one dose of a matched powder-in-capsule placebo will be administered immediately after breakfast.
Experimental: 100 mg PF-05175157 or Placebo; Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.	Drug: PF-05175157 or Placebo; One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.; Drug: PF-05175157 or Placebo; One dose of PF-05175157 will be administered as a powder-in-capsule immediately after breakfast; correspondingly, one dose of a matched powder-in-capsule placebo will be administered immediately after breakfast.
Experimental: 300 mg PF-05175157 or Placebo; Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.	Drug: PF-05175157 or Placebo; One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.; Drug: PF-05175157 or Placebo; One dose of PF-05175157 will be administered as a powder-in-capsule immediately after breakfast; correspondingly, one dose of a matched powder-in-capsule placebo will be administered immediately after breakfast.
Experimental: 600 mg PF-05175157 or Placebo; Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.	Drug: PF-05175157 or Placebo; One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.; Drug: PF-05175157 or Placebo; One dose of PF-05175157 will be administered as a powder-in-capsule immediately after breakfast; correspondingly, one dose of a matched powder-in-capsule placebo will be administered immediately after breakfast.
Experimental: 800 mg PF-05175157 or Placebo; Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.	Drug: PF-05175157 or Placebo; One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.; Drug: PF-05175157 or Placebo; One dose of PF-05175157 will be administered as a powder-in-capsule immediately after breakfast; correspondingly, one dose of a matched powder-in-capsule placebo will be administered immediately after breakfast.
Experimental: xxx mg PF-05175157 or Placebo; Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.	Drug: PF-05175157 or Placebo; One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.; Drug: PF-05175157 or Placebo; One dose of PF-05175157 will be administered as a powder-in-capsule immediately after breakfast; correspondingly, one dose of a matched powder-in-capsule placebo will be administered immediately after breakfast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Exploratory pharmacodynamic biomarkers	5 months

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: November 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 10, 2011
• First Submitted That Met QC Criteria: January 10, 2011
• First Posted (Estimate): January 11, 2011

Study Record Updates

• Last Update Posted (Estimate): October 12, 2011
• Last Update Submitted That Met QC Criteria: October 7, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: PK; Phase 1; Healthy Subjects; Safety and Tolerability; Single Ascending Dose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: B1731001