BMS Reverse Cholesterol Transport (RCT) Study

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01031862
First received: December 14, 2009
Last updated: June 24, 2010
Last verified: December 2009
  Purpose

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.


Condition Intervention
Healthy
Other: 3H-Cholesterol

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Presence of the tracer in feces [ Time Frame: Time zero to 96 Hour inclusive ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: November 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Healthy Volunteers
12 healthy volunteers
Other: 3H-Cholesterol
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men and women between the ages of 18 and 70
  2. Female subjects must be of non-childbearing potential. They must have been surgically sterilized at least 6 months prior to screening or be postmenopausal. Postmenopausal women must have no regular menstrual bleeding for at least 2 years prior to inclusion. .
  3. Subjects must be in good overall health
  4. Subjects must be able to comprehend and willing to provide a signed IRB approved Informed Consent Form.
  5. Subjects must be willing to comply with all study-related procedures.

Exclusion Criteria:

  1. Known cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease
  2. History of diabetes mellitus or fasting glucose > 126 mg/dL at the screening visit
  3. History of any other endocrine disease
  4. History of a non-skin malignancy within the previous 5 years
  5. Anemia; Hemoglobin less than 10 g/dL
  6. Renal insufficiency as defined by creatinine ³ 1.3 mg/dl
  7. Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition
  8. History of hypertension
  9. Use of warfarin, or any known coagulopathy and /or elevated PT/PTT >1.5 x ULN
  10. Self-reported history of HIV positive
  11. Previous organ transplantation
  12. Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as ALT or AST > 1x ULN, or self-reported history of positive Hepatitis B or Hepatitis C test result
  13. Any major surgical procedure that occurred within the previous 3 months of the screening visit
  14. Use of tobacco products currently or during the previous 30 days
  15. History of drug abuse (< 3 years)
  16. Regular use of alcoholic beverages (> 2 drinks/day)
  17. Body mass index (BMI) > 30 kg/m2 or < 18.5 kg/m2
  18. Participation in an investigational drug study within 6 weeks prior to the screening visit
  19. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study will be excluded.
  20. Use of lipid lowering drugs within the 6 weeks prior to dosing or during the study
  21. Use of other prescription or non-prescription drugs (including vitamins and herbal supplements, but excluding replacement hormone therapy) within 2 weeks prior to dosing or during the study, however, acetaminophen up to 2g/day is acceptable.
  22. Male subjects who plan to conceive a child within 3 months of the conclusion of the study.
  Contacts and Locations
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: NCT01031862

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Bristol-Myers Squibb
Investigators
Principal Investigator: Marina Cuchel, MD, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Marina Cuchel MD, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01031862     History of Changes
Other Study ID Numbers: 810035, CV 197-003
Study First Received: December 14, 2009
Last Updated: June 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
healthy volunteer
reverse cholesterol transport
RCT
3H

ClinicalTrials.gov processed this record on August 19, 2014