BMS Reverse Cholesterol Transport (RCT) Study
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|ClinicalTrials.gov Identifier: NCT01031862|
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : June 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: 3H-Cholesterol||Not Applicable|
The study will use 3H-cholesterol bound to albumin (particulate cholesterol) to assess the ability of HDL to transport cholesterol to the liver to be eliminated. This process is called Reverse Cholesterol transport and is one of the main mechanisms by which HDL protect against atherosclerotic cardiovascular disease. The availability of a method to assess RCT is important for the development of new drugs which affect RCT and may result in useful treatments for atherosclerosis.
This study will evaluate the use of radiolabeled particulate cholesterol administered intravenously in association with albumin, as a method to study reverse cholesterol transport (RCT) in humans by analyzing changes in the tracer activity in total plasma and lipoproteins. The study population is healthy volunteers.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Pilot Study to Evaluate the Use of 3H Particulate Cholesterol as a Method to Study Reverse Cholesterol Transport in Humans|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
12 healthy volunteers
A single dose of 25-50 μCi 3H free cholesterol -albumin complexes (containing approximately 0.1 - 0.3 mg of cholesterol) will be administered intravenously as a slow bolus injection within 1-2 minutes.
- Changes in the tracer activity in total plasma and lipoproteins. [ Time Frame: 10 minutes, Zero hour, 5, 10, 15, 30, 45 minutes, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 18, 24, 48, 72, 96 Hours ]
- Presence of the tracer in feces [ Time Frame: Time zero to 96 Hour inclusive ]
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): NCT01031862
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Marina Cuchel, MD, PhD||University of Pennsylvania|