Effect Of GW501516X On How The Heart Obtains And Uses Energy

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00318617
• Other study ID #: PAD100964
• Status: Terminated
• Phase: N/A
• First received: April 25, 2006
• Last updated: March 15, 2012
• Start date: December 2005

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Dyslipidaemias
• Dyslipidemias
• Heart Failure

Intervention

Drug:
• GW510516X

Locations

Country	Name	City	State
United States	GSK Investigational Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy-related chemicals and heart contraction, determined by MRI measurement of the heart.
Secondary	Additional energy-related chemicals, determined by MRI measurement of the heart. Blood proteins. Safety of GW501516X.