Effect Of Single-Dose PF-05175157 On Metabolic And Cardiopulmonary Parameters



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 40
Updated:11/23/2013
Start Date:April 2013
End Date:December 2013
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

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A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study To Assess The Effect Of PF-05175157 As A Single Oral Dose On Metabolic And Cardiopulmonary Parameters During Steady State And Graded Exercise In Healthy Subjects


This study is designed to assess the effect of one single dose of PF-05175157 on metabolic
and cardiopulmonary parameters before, during and after treadmill exercise in healthy
volunteers.


Inclusion Criteria:

- Healthy male and/or female subjects of non child bearing potential only, between the
ages of 18 and 40 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).

- Body Mass Index (BMI) of 18 to 28 kg/m2; and a total body weight >50 kg (110 lbs).

- Subjects with maximum effort studies (peak RER >1.05) and normal exercise capacity as
defined by peak VO2 ≥80% and ≤120% of predicted and no evidence of inducible ischemia
or significant arrhythmia at the time of peak aerobic capacity testing 3 (±1) days
prior to initiation of the study.

Exclusion Criteria:

- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- 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 -3 (±1).

- Dry eye symptoms
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