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Trial record 2 of 4 for:    GW501516
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Effect Of GW501516X On How The Heart Obtains And Uses Energy

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ClinicalTrials.gov Identifier: NCT00318617
Recruitment Status : Terminated
First Posted : April 27, 2006
Last Update Posted : March 19, 2012
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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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.

Condition or disease Intervention/treatment
Dyslipidaemias Heart Failure Drug: GW510516X

Study Design
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Study Type : Observational
Enrollment : 30 participants
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 Start Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: GW 501516

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Energy-related chemicals and heart contraction, determined by MRI measurement of the heart.

Secondary Outcome Measures :
  1. Additional energy-related chemicals, determined by MRI measurement of the heart. Blood proteins. Safety of GW501516X.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00318617


Locations
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United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00318617    
Other Study ID Numbers: PAD100964
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: February 2011
Keywords provided by GlaxoSmithKline:
peroxisome proliferator activated receptors,
PPARs,
Heart Failure,
cardiac energetics,
 MRI,
GW501516X
fatty acid metabolism,
Additional relevant MeSH terms:
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Heart Failure
Dyslipidemias
Heart Diseases
 Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases