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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 30, 2016
Last verified: March 2016
Results First Received: February 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Healthy
Interventions: Drug: PF-05175157
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PF-05175157 Then Placebo Participants who met the pre-defined cardiopulmonary exercise test (CPET) criteria, received single dose of PF-05175157 600 milligram (mg) capsule orally in first intervention period then single dose of placebo matched to PF-05175157 capsule, 600 mg orally in second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
Placebo Then PF-05175157 Participants who met the pre-defined CPET criteria, received single dose of placebo matched to PF-05175157, 600 mg capsule orally in first intervention period then single dose of PF-05175157 600 mg capsule orally in second intervention period. A washout period at least of 7-10 days was maintained between each intervention period.

Participant Flow for 3 periods

Period 1:   First Intervention Period (1 Day)
    PF-05175157 Then Placebo     Placebo Then PF-05175157  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     0  

Period 2:   Washout Period (at Least 7-10 Days)
    PF-05175157 Then Placebo     Placebo Then PF-05175157  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     0  

Period 3:   Second Intervention Period (1 Day)
    PF-05175157 Then Placebo     Placebo Then PF-05175157  
STARTED     6     6  
COMPLETED     6     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline analysis population included all participants who performed the peak aerobic capacity test, were randomized and had at least 1 dose of randomized treatment.

Reporting Groups
  Description
Overall Participants All randomized participants who received single dose of PF-05175157 600 mg capsule or single dose of placebo matched to PF-05175157 600 mg capsule in either first or second intervention period.

Baseline Measures
    Overall Participants  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean (Standard Deviation)
  23.8  (2.5)  
Gender  
[units: participants]
 
Female     0  
Male     12  
Oxygen Uptake Efficiency Slope (OUES)  
[units: milliliter per log10*liter [mL/log10(L)]]
Mean (Standard Deviation)
  3163.333  (3200.000)  
Volume of oxygen  
[units: milliliter per kilogram per minute]
Mean (Standard Deviation)
  41.033  (3.6084)  
Respiratory Exchange Ratio  
[units: ratio]
Mean (Standard Deviation)
  1.313  (0.0881)  
Minute Ventilation and Carbon Dioxide Production (VE/VCO2 slope)  
[units: unitless]
Mean (Standard Deviation)
  20.800  (3.5545)  
Volume of Oxygen (VO2) at Anaerobic Threshold  
[units: milliliter (mL)]
Mean (Standard Deviation)
  19.467  (2.6800)  
Oxygen pulse  
[units: milliliter per beat (mL/beat)]
Mean (Standard Deviation)
  16.808  (2.0518)  
Aerobic Efficiency  
[units: milliliter per watt (mL/watt)]
Mean (Standard Deviation)
  10.442  (0.8544)  
Physical Work Capacity  
[units: beats per minute (bpm)]
Mean (Standard Deviation)
  154.750  (25.3094)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 20 Minutes Pre-dose   [ Time Frame: 20 minutes pre-dose ]

2.  Primary:   Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 1 Hour 30 Minutes Post-dose   [ Time Frame: 1 hour 30 minutes post-dose ]

3.  Primary:   Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 2 Hours 5 Minutes Post-dose   [ Time Frame: 2 hours 5 minutes post-dose ]

4.  Primary:   Cardiopulmonary Exercise Test: Oxygen Uptake Efficiency Slope (OUES): 1 Hour 40 Minute Post-dose   [ Time Frame: 1 hour 40 minutes post-dose ]

5.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to 5-10 days after last dose of study drug (up to 25 days) ]

6.  Secondary:   Number of Participants With Clinically Significant Laboratory Abnormalities   [ Time Frame: Baseline up-to 3 hours post-dose ]

7.  Secondary:   Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data   [ Time Frame: Baseline up-to 3 hours post-dose ]

8.  Secondary:   Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data: Electrocardiogram (ECG) Parameters   [ Time Frame: Baseline up-to 3 hour post-dose ]

9.  Secondary:   Cardiopulmonary Exercise Test: Peak Volume of Oxygen (VO2)   [ Time Frame: 1 hour 40 minutes post-dose ]

10.  Secondary:   Cardiopulmonary Exercise Test: Respiratory Exchange Ratio (RER)   [ Time Frame: 1 hour 40 minutes post-dose ]

11.  Secondary:   Cardiopulmonary Exercise Test: Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)   [ Time Frame: 1 hour 40 minutes post-dose ]

12.  Secondary:   Cardiopulmonary Exercise Test: Volume of Oxygen (VO2) at Anaerobic Threshold (AT)   [ Time Frame: 1 hour 40 minutes post-dose ]

13.  Secondary:   Cardiopulmonary Exercise Test: Oxygen (O2) Pulse   [ Time Frame: 1 hour 40 minutes post-dose ]

14.  Secondary:   Cardiopulmonary Exercise Test: Oxygen (O2) Kinetics   [ Time Frame: 1 hour 40 minutes post-dose ]

15.  Secondary:   Cardiopulmonary Exercise Test: Aerobic Efficiency   [ Time Frame: 1 hour 40 minutes post-dose ]

16.  Secondary:   Cardiopulmonary Exercise Test: Physical Work Capacity at a Heart Rate of 130 Beats Per Minute (PWC 130)   [ Time Frame: 1 hour 40 minutes post-dose ]

17.  Secondary:   Cardiac Structure: Left Ventricular Volume   [ Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

18.  Secondary:   Change From Baseline in the Left Ventricular Volume   [ Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

19.  Secondary:   Cardiac Structure: Left Ventricular Wall Thickness   [ Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

20.  Secondary:   Cardiac Structure: Left Ventricular Geometry   [ Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

21.  Secondary:   Cardiac Structure: Right Ventricular Dimension   [ Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

22.  Secondary:   Change From Baseline in Right Ventricular Dimension   [ Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

23.  Secondary:   Cardiac Structure: Atrial Volume   [ Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

24.  Secondary:   Change From Baseline in Atrial Volumes   [ Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

25.  Secondary:   Systolic Function: Ejection Fraction   [ Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

26.  Secondary:   Change From Baseline in Ejection Fraction   [ Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

27.  Secondary:   Systolic Function: Peak Contractile Velocity   [ Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

28.  Secondary:   Change From Baseline in Peak Contractile Velocity   [ Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

29.  Secondary:   Systolic Function: Rotation/Torsion   [ Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

30.  Secondary:   Systolic Function: Global Strain Rate   [ Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes ]

31.  Secondary:   Change From Baseline in Systolic Global Strain Rate   [ Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

32.  Secondary:   Trans-mitral Doppler: Ratio   [ Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes ]

33.  Secondary:   Change From Baseline in Trans-mitral Doppler Ratio   [ Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

34.  Secondary:   Trans-mitral Doppler: Time   [ Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

35.  Secondary:   Change From Baseline in Trans-mitral Doppler Time   [ Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

36.  Secondary:   Early and Late Peak Tissue Velocity   [ Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

37.  Secondary:   Change From Baseline in Early and Late Peak Velocity   [ Time Frame: 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

38.  Secondary:   Diastolic Strain Rate   [ Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

39.  Secondary:   Peak Diastolic Untwisting Rate   [ Time Frame: 20 minutes pre-dose, 1 hour 30 minutes and 2 hours 5 minutes post-dose ]

40.  Secondary:   Plasma Metabolomic Profiles Before and Immediately Following Steady State and Incremental Exercise   [ Time Frame: 1 hour pre-dose, 1 hour 20 minutes and 2 hours 10 minutes post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01819922     History of Changes
Other Study ID Numbers: B1731008
Study First Received: February 24, 2013
Results First Received: February 29, 2016
Last Updated: March 30, 2016
Health Authority: United States: Food and Drug Administration