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CompletedNCT01031862Updated Dec 19, 2018

BMS Reverse Cholesterol Transport (RCT) Study

An interventional study of 3H-Cholesterol in Healthy, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-19.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Healthy

Keywords

  • healthy volunteer
  • reverse cholesterol transport
  • RCT
  • 3H
03

In context

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Other
    Healthy Volunteers

    12 healthy volunteers

    Other: 3H-Cholesterol

Interventions

  • Other3H-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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Presence of the tracer in feces

    Time frame: Time zero to 96 Hour inclusive

07

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01031862
Lead sponsor
University of Pennsylvania
Collaborators
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Dec 15, 2009
Start date
Nov 2009
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Dec 19, 2018

Study contacts

Marina Cuchel, MD, PhD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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