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Effect Of GW501516X On How The Heart Obtains And Uses Energy

Primary Purpose

Dyslipidaemias, Heart Failure

Status
Terminated
Phase
Locations
United States
Study Type
Observational
Intervention
GW510516X
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Dyslipidaemias focused on measuring peroxisome proliferator activated receptors,, PPARs,, Heart Failure,, cardiac energetics,, MRI,, GW501516X, fatty acid metabolism,

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion criteria: Non-smoking. Body Mass Index of greater than 27 and less than 32 and who weigh 120 kg (264 lbs) or less and have a waist circumference of greater than 95 cm (37.5 inches). Exclusion criteria: History of muscle disease, coagulation disorders, heart disease or abnormal heart rhythm (or a family history of early coronary artery disease). Documented diabetes, hypoglycemia, thyroid disfunction or adrenal disorder.

Sites / Locations

  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Energy-related chemicals and heart contraction, determined by MRI measurement of the heart.

Secondary Outcome Measures

Additional energy-related chemicals, determined by MRI measurement of the heart. Blood proteins. Safety of GW501516X.

Full Information

First Posted
April 25, 2006
Last Updated
March 15, 2012
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00318617
Brief Title
Effect Of GW501516X On How The Heart Obtains And Uses Energy
Official Title
A Two Part Study to Separately Evaluate the Effect of 4-week Treatment With GW501516X Relative to Placebo on Cardiac Energetics in a Randomized, Single-blind, Repeat Dose, Parallel Group Design in Healthy Male Subjects
Study Type
Observational

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Terminated
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the effect of a 4-week treatment period with GW501516X on how the heart obtains and uses energy. The energy of the heart will be measured by Magnetic Resonance Imaging (MRI). This study will also measure a number of other potential markers of drug activity, including levels of certain lipids (fats) and proteins in your blood. The data from this study may help researchers better understand the actions of this drug in the body and if this drug may be useful to treat patients with heart disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidaemias, Heart Failure
Keywords
peroxisome proliferator activated receptors,, PPARs,, Heart Failure,, cardiac energetics,, MRI,, GW501516X, fatty acid metabolism,

7. Study Design

Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW510516X
Primary Outcome Measure Information:
Title
Energy-related chemicals and heart contraction, determined by MRI measurement of the heart.
Secondary Outcome Measure Information:
Title
Additional energy-related chemicals, determined by MRI measurement of the heart. Blood proteins. Safety of GW501516X.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Non-smoking. Body Mass Index of greater than 27 and less than 32 and who weigh 120 kg (264 lbs) or less and have a waist circumference of greater than 95 cm (37.5 inches). Exclusion criteria: History of muscle disease, coagulation disorders, heart disease or abnormal heart rhythm (or a family history of early coronary artery disease). Documented diabetes, hypoglycemia, thyroid disfunction or adrenal disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Effect Of GW501516X On How The Heart Obtains And Uses Energy

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