Effect Of GW501516X On How The Heart Obtains And Uses Energy

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00318617

Enrollment

Registered

2006-04-27

Start date

2005-12-31

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidaemias, Heart Failure

Keywords

peroxisome proliferator activated receptors,, PPARs,, Heart Failure,, cardiac energetics,, MRI,, GW501516X, fatty acid metabolism,

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.

Interventions

DRUGGW510516X

Eligibility

Sex/Gender

MALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Energy-related chemicals and heart contraction, determined by MRI measurement of the heart.	—

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026