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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of this study is to investigate 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, lipoproteins and feces.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Group 1 is comprised of 6 healthy subjects with HDL-C levels between the 25th and 75th percentile. |
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| Group 2 | Other | Group 2 is comprised of 6 healthy subjects with high HDL-C levels > 75th percentile. |
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| Group 3 | Other | Group 2 is comprised of 6 healthy subjects with low HDL-C levels < 25th percentile. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3H-Cholesterol | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the tracer activity in total plasma and lipoproteins. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of the tracer in feces. | Time zero to 96 Hour inclusive |
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Inclusion Criteria:
Group 1 (6 subjects):
Group 2 (6 subjects):
Group 3 (6 subjects):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marina Cuchel, MD, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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