A Study To Evaluate The Effects Of PF-05175157 In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01537497
First received: February 17, 2012
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

The primary purpose of this study is to evaluate pharmacodynamics of single oral doses of PF-05175157 in a dose-dependent fashion in healthy volunteers


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Phase 1 Four-Arm Parallel Group, Placebo-Controlled Study To Evaluate The Effects Of Single Doses Of PF- 05175157 At Three Dose Levels On Pharmacodynamic And Metabolic Parameters In Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Modulation of carbohydrate and lipid metabolism [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax of PF-05175157 after single oral doses [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Tmax of PF-05175157 after single oral doses [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Area under the curve (AUC) of PF-05175157 after single oral doses [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 100 mg PF-05175157
The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
Drug: PF-05175157
One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.
Experimental: 250 mg PF-05175157
The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
Drug: PF-05175157
One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.
Experimental: 600 mg PF-05175157
The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
Drug: PF-05175157
One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.
Placebo Comparator: Placebo
The chance of receiving 100 mg, 250 mg, 600 mg or placebo will be randomized.
Drug: Placebo
One single oral dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 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 measurement, 12 lead ECG and clinical laboratory tests. In addition, subjects must have normal pulmonary function tests and normal ocular findings.
  • Women must be of non-childbearing potential.
  • Body Mass Index (BMI) of 19.5 35.5 kg/m2, and a total body weight of > 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 and seasonal allergies at time of dosing).
  • 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 -7.
  • Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537497

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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01537497     History of Changes
Other Study ID Numbers: B1731013
Study First Received: February 17, 2012
Last Updated: July 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 1
Single Doses
Pharmacodynamics
Healthy Volunteers

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

ClinicalTrials.gov processed this record on September 14, 2014