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
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: PF-05175157
Drug: Placebo
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: April 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-05175157 Drug: PF-05175157
600 mg as powder in capsule, one dose within 5 minutes prior to AM meal
Placebo Comparator: Placebo Drug: Placebo
Placebo powder in capsule, one dose within 5 minutes prior to AM meal

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01819922

Locations
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01819922     History of Changes
Other Study ID Numbers: B1731008
Study First Received: February 24, 2013
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Cardiopulmonary exercise testing
metabolic parameters
Diabetes Mellitus Type 2

ClinicalTrials.gov processed this record on September 18, 2014