Effect Of Single-Dose PF-05175157 On Metabolic And Cardiopulmonary Parameters
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||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|
- 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
- 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
|Study Start Date:||April 2013|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
600 mg as powder in capsule, one dose within 5 minutes prior to AM meal
|Placebo Comparator: Placebo||
Placebo powder in capsule, one dose within 5 minutes prior to AM meal