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A Study Of PF-05175157 In Healthy Volunteers

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-05175157 or Placebo
PF-05175157 or Placebo
PF-05175157 or Placebo
PF-05175157 or Placebo
PF-05175157 or Placebo
PF-05175157 or Placebo
PF-05175157 or Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring Single Ascending Dose, Phase 1, Safety and Tolerability, PK, Healthy Subjects

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

10 mg PF-05175157 or Placebo

30 mg PF-05175157 or Placebo

100 mg PF-05175157 or Placebo

300 mg PF-05175157 or Placebo

600 mg PF-05175157 or Placebo

800 mg PF-05175157 or Placebo

xxx mg PF-05175157 or Placebo

Arm Description

Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.

Outcomes

Primary Outcome Measures

Safety and tolerability of escalating single doses of PF-05175157 in healthy subjects
Single dose pharmacokinetics of PF-05175157

Secondary Outcome Measures

Exploratory pharmacodynamic biomarkers

Full Information

First Posted
January 10, 2011
Last Updated
October 7, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01274663
Brief Title
A Study Of PF-05175157 In Healthy Volunteers
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Single Ascending Dose, Phase 1, Safety and Tolerability, PK, Healthy Subjects

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10 mg PF-05175157 or Placebo
Arm Type
Experimental
Arm Description
Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
Arm Title
30 mg PF-05175157 or Placebo
Arm Type
Experimental
Arm Description
Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
Arm Title
100 mg PF-05175157 or Placebo
Arm Type
Experimental
Arm Description
Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
Arm Title
300 mg PF-05175157 or Placebo
Arm Type
Experimental
Arm Description
Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
Arm Title
600 mg PF-05175157 or Placebo
Arm Type
Experimental
Arm Description
Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
Arm Title
800 mg PF-05175157 or Placebo
Arm Type
Experimental
Arm Description
Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
Arm Title
xxx mg PF-05175157 or Placebo
Arm Type
Experimental
Arm Description
Subjects will receive one dose of PF-05175157 or one dose of Placebo (2:1 ratio) in random order.
Intervention Type
Drug
Intervention Name(s)
PF-05175157 or Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PF-05175157 or Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PF-05175157 or Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PF-05175157 or Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PF-05175157 or Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PF-05175157 or Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PF-05175157 or Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety and tolerability of escalating single doses of PF-05175157 in healthy subjects
Time Frame
5 months
Title
Single dose pharmacokinetics of PF-05175157
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Exploratory pharmacodynamic biomarkers
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1731001&StudyName=A%20Study%20Of%20PF-05175157%20In%20Healthy%20Volunteers
Description
To obtain contact information for a study center near you, click here.

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A Study Of PF-05175157 In Healthy Volunteers

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