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OpenTrials
Completed

NCT Number: NCT01537497

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-05175157

Drug

One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.

Placebo

Drug

One single oral dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.

Primary outcomes

  1. Modulation of carbohydrate and lipid metabolism

    Time frame: 24 hours

Secondary outcomes

  1. Cmax of PF-05175157 after single oral doses

    Time frame: 24 hours

  2. Tmax of PF-05175157 after single oral doses

    Time frame: 24 hours

  3. Area under the curve (AUC) of PF-05175157 after single oral doses

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 23, 2012
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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