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Completed

NCT Number: NCT01433380

A Study To Evaluate PF-05175157 In Healthy Volunteers

The primary purpose of this study is to evaluate the pharmacodynamics of single oral doses of PF-05175157 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

Baton Rouge, Louisiana, 70808, 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 examination.
  • Body Mass Index of 20.0 35.0 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, but excluding untreated, asymptomatic, 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 0.
  • 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 dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.

Placebo

Drug

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

Primary outcomes

  1. Changes in carbohydrate and lipid metabolism

    Time frame: 24 hours

Secondary outcomes

  1. Pharmacokinetics: 0.5, 1, 1.5, 2.5, 6.5, 10.5, 24 hrs after dosing, parameters: Cmax, Tmax and Area under the Curve (AUC)

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase 1 Study To Evaluate The Effect Of Single Doses Of Pf-05175157 On Pharmacodynamic And Metabolic Parameters In Healthy Volunteers

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 13, 2011
Registry last updated
May 18, 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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