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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 : August 3, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Pennsylvania

December 14, 2009
December 15, 2009
August 3, 2018
November 2009
June 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01031862 on ClinicalTrials.gov Archive Site
Presence of the tracer in feces [ Time Frame: Time zero to 96 Hour inclusive ]
Same as current
Not Provided
Not Provided
 
BMS Reverse Cholesterol Transport (RCT) Study
A Pilot Study to Evaluate the Use of 3H Particulate Cholesterol as a Method to Study Reverse Cholesterol Transport in Humans
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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
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.
Healthy Volunteers
12 healthy volunteers
Intervention: Other: 3H-Cholesterol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
Same as current
June 2010
June 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01031862
810035
CV 197-003
No
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
Bristol-Myers Squibb
Principal Investigator: Marina Cuchel, MD, PhD University of Pennsylvania
University of Pennsylvania
August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP