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

Tracking Information

First Submitted Date

April 25, 2006

First Posted Date

April 27, 2006

Last Update Posted Date

March 19, 2012

Study Start Date

December 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Same as current

Change History

Current Secondary Outcome Measures

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

Original Secondary Outcome Measures

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

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

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.

Detailed Description

Not Provided

Study Type

Observational

Study Design

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition

Dyslipidaemias
Heart Failure

Intervention

Drug: GW510516X

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Terminated

Enrollment

Original Enrollment

Same as current

Study Completion Date

Not Provided

Primary Completion Date

Not Provided

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.

Sex/Gender

Sexes Eligible for Study:

Male

Ages

18 Years to 40 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

United States

Removed Location Countries

Administrative Information

NCT Number

NCT00318617

Other Study ID Numbers

PAD100964

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

GlaxoSmithKline

Study Sponsor

GlaxoSmithKline

Collaborators

Not Provided

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

PRS Account

GlaxoSmithKline

Verification Date

February 2011

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