Phase 1
Completed N=12
Effect Of Single-Dose PF-05175157 On Metabolic And Cardiopulmonary Parameters
Healthy
Source: ClinicalTrials.gov NCT01819922 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2016
Primary outcomePrimary: Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 20 Minutes Pre-dose — -19.779; -20.483 percent change
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 20 Minutes Pre-dose |
-19.779; -20.483 | — |
| PRIMARY Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 1 Hour 30 Minutes Post-dose |
-19.728; -20.183 | — |
| PRIMARY Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 2 Hours 5 Minutes Post-dose |
-24.058; -24.587 | — |
| PRIMARY Cardiopulmonary Exercise Test: Oxygen Uptake Efficiency Slope (OUES): 1 Hour 40 Minute Post-dose |
3192.500; 3165.833 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
0; 2; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Laboratory Abnormalities |
4; 6 | — |
| SECONDARY Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data: Electrocardiogram (ECG) Parameters |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Cardiopulmonary Exercise Test: Peak Volume of Oxygen (VO2) |
41.325; 42.092 | — |
| SECONDARY Cardiopulmonary Exercise Test: Respiratory Exchange Ratio (RER) |
0.984; 1.013 | — |
| SECONDARY Cardiopulmonary Exercise Test: Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope) |
22.325; 21.375 | — |
| SECONDARY Cardiopulmonary Exercise Test: Volume of Oxygen (VO2) at Anaerobic Threshold (AT) |
19.008; 18.633 | — |
| SECONDARY Cardiopulmonary Exercise Test: Oxygen (O2) Pulse |
16.692; 16.850 | — |
| SECONDARY Cardiopulmonary Exercise Test: Oxygen (O2) Kinetics |
— | — |
| SECONDARY Cardiopulmonary Exercise Test: Aerobic Efficiency |
10.358; 10.483 | — |
| SECONDARY Cardiopulmonary Exercise Test: Physical Work Capacity at a Heart Rate of 130 Beats Per Minute (PWC 130) |
156.583; 156.667 | — |
| SECONDARY Cardiac Structure: Left Ventricular Volume |
76.750; 76.333; 77.167; 77.333; 85.250; 85.000 | — |
| SECONDARY Change From Baseline in the Left Ventricular Volume |
0.417; 1.000; 8.500; 8.667 | — |
| SECONDARY Cardiac Structure: Left Ventricular Wall Thickness |
— | — |
| SECONDARY Cardiac Structure: Left Ventricular Geometry |
— | — |
| SECONDARY Cardiac Structure: Right Ventricular Dimension |
24.250; 23.704; 24.408; 23.975; 24.203; 23.642 | — |
| SECONDARY Change From Baseline in Right Ventricular Dimension |
0.158; 0.271; -0.047; -0.062; -0.325; 0.350 | — |
| SECONDARY Cardiac Structure: Atrial Volume |
47.000; 50.750; 47.000; 49.833; 42.917; 44.917 | — |
| SECONDARY Change From Baseline in Atrial Volumes |
0.000; -0.917; -4.083; -5.833; 1.417; 1.333 | — |
| SECONDARY Systolic Function: Ejection Fraction |
63.190; 63.058; 62.525; 62.633; 72.462; 72.949 | — |
| SECONDARY Change From Baseline in Ejection Fraction |
-0.665; -0.426; 9.272; 9.891 | — |
| SECONDARY Systolic Function: Peak Contractile Velocity |
7.625; 9.025; 7.758; 9.083; 12.875; 13.925 | — |
| SECONDARY Change From Baseline in Peak Contractile Velocity |
0.133; 0.058; 5.250; 4.900 | — |
| SECONDARY Systolic Function: Rotation/Torsion |
— | — |
| SECONDARY Systolic Function: Global Strain Rate |
-1.043; -1.124; -1.047; -1.078; -1.845; -1.916 | — |
| SECONDARY Change From Baseline in Systolic Global Strain Rate |
-0.003; 0.047; -0.802; -0.792 | — |
| SECONDARY Trans-mitral Doppler: Ratio |
186.894; 182.236; 184.050; 190.424; 134.205; 125.156 | — |
| SECONDARY Change From Baseline in Trans-mitral Doppler Ratio |
-2.844; 8.188; -57.803; -61.330 | — |
| SECONDARY Trans-mitral Doppler: Time |
168.333; 158.917; 166.417; 160.750; 179.091; 173.727 | — |
| SECONDARY Change From Baseline in Trans-mitral Doppler Time |
-1.917; 1.833; 11.273; 14.273 | — |
| SECONDARY Early and Late Peak Tissue Velocity |
9.892; 10.375; 10.017; 10.342; 11.600; 11.825 | — |
| SECONDARY Change From Baseline in Early and Late Peak Velocity |
-0.300; 0.125; 1.713; 1.144; 0.125; -0.033 | — |
| SECONDARY Diastolic Strain Rate |
— | — |
| SECONDARY Peak Diastolic Untwisting Rate |
— | — |
| SECONDARY Plasma Metabolomic Profiles Before and Immediately Following Steady State and Incremental Exercise |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01819922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.