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Effect Of GW501516X On How The Heart Obtains And Uses Energy

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00318617
First received: April 25, 2006
Last updated: March 15, 2012
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention
Dyslipidaemias
Heart Failure
 Drug: GW510516X

Study Type: Observational
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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.

Estimated Enrollment: 30
Study Start Date: December 2005
Intervention Details:
    Drug: GW510516X
    Other Name: GW510516X
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318617

Locations
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00318617     History of Changes
Other Study ID Numbers: PAD100964
Study First Received: April 25, 2006
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
peroxisome proliferator activated receptors,
PPARs,
Heart Failure,
cardiac energetics,
 MRI,
GW501516X
fatty acid metabolism,

Additional relevant MeSH terms:
Heart Failure
Dyslipidemias
Heart Diseases
 Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013