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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01819922
First received: February 24, 2013
Last updated: March 12, 2014
Last verified: March 2014

February 24, 2013
March 12, 2014
April 2013
October 2013   (final data collection date for primary outcome measure)
  • Global (systolic) strain by echocardiography [ Time Frame: 180 min ] [ Designated as safety issue: No ]

    Strain and strain rate imaging (systolic function) will be performed by speckled tracking analysis.

    Peak global strain will be calculated as the average strain in the basal, mid, and apical LV as measured in the apical 4-chamber view.

  • Oxygen uptake efficiency slope (OUES)during cardiopulmonary exercise test. [ Time Frame: 180 min ] [ Designated as safety issue: No ]
    OUES is is the relationship between minute ventilation and VO2 derived from recognition that VE increases logarithmically compared to VO2
  • Global (systolic) strain by echocardiography [ Time Frame: 180 min ] [ Designated as safety issue: No ]
  • Oxygen uptake efficiency slope (OUES)during cardiopulmonary exercise test. [ Time Frame: 180 min ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01819922 on ClinicalTrials.gov Archive Site
Cardiovascular exercise and cardiovascular function endpoints [ Time Frame: 180 min ] [ Designated as safety issue: No ]
These endpoints include the following parameters: Peak VO2, VE/VCO2 slope, VO2 at anaerobic threshold, oxygen pulse (VO2/Heart Rate), oxygen kinetics (Deficit and Debt), aerobic efficiency (VO2/Work), PWC 130: physical work capacity at a heart rate of 130 beats per minute
Cardiovascular exercise and cardiovascular function endpoints [ Time Frame: 180 min ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect Of Single-Dose PF-05175157 On Metabolic And Cardiopulmonary Parameters
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-05175157
    600 mg as powder in capsule, one dose within 5 minutes prior to AM meal
  • Drug: Placebo
    Placebo powder in capsule, one dose within 5 minutes prior to AM meal
  • Experimental: PF-05175157
    Intervention: Drug: PF-05175157
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01819922
B1731008
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP