Effect Of GW501516X On How The Heart Obtains And Uses Energy
This study has been terminated.
Information provided by (Responsible Party):
First received: April 25, 2006
Last updated: March 15, 2012
Last verified: February 2011
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.
||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
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:
| Study Start Date:
Other Name: GW510516X
|Ages Eligible for Study:
||18 Years to 40 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318617
|GSK Investigational Site
|Philadelphia, Pennsylvania, United States, 19104 |
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 25, 2006
||March 15, 2012
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
ClinicalTrials.gov processed this record on March 25, 2015
peroxisome proliferator activated receptors,
fatty acid metabolism,