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A Study Of PF-05175157 In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01274663
First received: January 10, 2011
Last updated: October 7, 2011
Last verified: October 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: PF-05175157 or Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability of escalating single doses of PF-05175157 in healthy subjects [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]
  • Single dose pharmacokinetics of PF-05175157 [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exploratory pharmacodynamic biomarkers [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: November 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.
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.
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.
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 immediately after breakfast; correspondingly, one dose of a matched powder-in-capsule placebo will be administered immediately after breakfast.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274663

Locations
United States, Florida
Pfizer Investigational Site
South Miami, Florida, United States, 33143
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01274663     History of Changes
Other Study ID Numbers: B1731001
Study First Received: January 10, 2011
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Single Ascending Dose
Phase 1
Safety and Tolerability
PK
Healthy Subjects

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013