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

NCT01819922 | Completed Phase 1 Results

• 1 other identifier: B1731008
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Cardiopulmonary exercise testing; metabolic parameters; Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (4)

• Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 20 Minutes Pre-dose

  Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.

  20 minutes pre-dose

• Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 1 Hour 30 Minutes Post-dose

  Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.

  1 hour 30 minutes post-dose

• Systolic Function: Global Longitudinal Left Ventricular (LV) Strain: 2 Hours 5 Minutes Post-dose

  Global longitudinal left ventricular strain was defined as the percent change in left ventricular longitudinal dimension in comparison to its original dimension. Global longitudinal LV strain was assessed by echocardiography using speckled tracking analysis.

  2 hours 5 minutes post-dose

• Cardiopulmonary Exercise Test: Oxygen Uptake Efficiency Slope (OUES): 1 Hour 40 Minute Post-dose

  OUES was defined as an index of cardiopulmonary functional reserve that was based upon a submaximal exercise effort. OUES relates oxygen uptake to total ventilation during exercise.

  1 hour 40 minutes post-dose

Secondary Outcomes (36)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline up to 5-10 days after last dose of study drug (up to 25 days)

• Number of Participants With Clinically Significant Laboratory Abnormalities

  Baseline up-to 3 hours post-dose

• Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data

  Baseline up-to 3 hours post-dose

• Number of Participants With Categorical Post-dose Cardiovascular Monitoring Data: Electrocardiogram (ECG) Parameters

  Baseline up-to 3 hour post-dose

• Cardiopulmonary Exercise Test: Peak Volume of Oxygen (VO2)

  1 hour 40 minutes post-dose

Study Arms (2)

PF-05175157

EXPERIMENTAL

Drug: PF-05175157

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PF-05175157 DRUG

600 mg as powder in capsule, one dose within 5 minutes prior to AM meal

PF-05175157

Placebo DRUG

Placebo powder in capsule, one dose within 5 minutes prior to AM meal

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2013
• First Posted: March 28, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 2, 2016
• Results First Posted: May 2, 2016

Record last verified: 2016-03

Locations

US (1)