NCT00318617

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
Last Updated

March 19, 2012

Status Verified

February 1, 2011

First QC Date

April 25, 2006

Last Update Submit

March 15, 2012

Conditions

DyslipidaemiasHeart Failure

Keywords

peroxisome proliferator activated receptors,PPARs,Heart Failure,cardiac energetics,MRI,GW501516Xfatty acid metabolism,

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

GW510516XDRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2006

First Posted

April 27, 2006

Study Start

December 1, 2005

Last Updated

March 19, 2012

Record last verified: 2011-02

Locations

US(1)