BMS Reverse Cholesterol Transport (RCT) Study
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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|
- 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 ] [ Designated as safety issue: No ]
- Presence of the tracer in feces [ Time Frame: Time zero to 96 Hour inclusive ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01031862
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Marina Cuchel, MD, PhD||University of Pennsylvania|