BMS Reverse Cholesterol Transport (RCT) Study

NCT01031862 | Completed

• 2 other identifiers: 810035CV 197-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

healthy volunteer; reverse cholesterol transport; RCT; 3H

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Presence of the tracer in feces

  Time zero to 96 Hour inclusive

Study Arms (1)

Healthy Volunteers

OTHER

12 healthy volunteers

Other: 3H-Cholesterol

Interventions

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.

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 18 and 70
• Subjects must be in good overall health
• Subjects must be able to comprehend and willing to provide a signed IRB approved Informed Consent Form.
• Subjects must be willing to comply with all study-related procedures.

You may not qualify if:

• Known cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease
• History of diabetes mellitus or fasting glucose \> 126 mg/dL at the screening visit
• History of any other endocrine disease
• History of a non-skin malignancy within the previous 5 years
• Anemia; Hemoglobin less than 10 g/dL
• Renal insufficiency as defined by creatinine ³ 1.3 mg/dl
• Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition
• History of hypertension
• Use of warfarin, or any known coagulopathy and /or elevated PT/PTT \>1.5 x ULN
• Self-reported history of HIV positive
• Previous organ transplantation
• 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
• Any major surgical procedure that occurred within the previous 3 months of the screening visit
• Use of tobacco products currently or during the previous 30 days
• History of drug abuse (\< 3 years)

Sponsors & Collaborators

• University of Pennsylvania: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Marina Cuchel, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 15, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 19, 2018

Record last verified: 2018-08

Locations

US (1)