A Study of the Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects (0000-108)(COMPLETED)

NCT ID: NCT01101763

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2008-12-31

Brief Summary

This is a 2-part pilot study in healthy male subjects to evaluate plasma enrichment kinetics of [13C3,4]-cholesterol (Part I) and to assess the test-retest reproducibility (Part II) of Reverse Cholesterol Transport (RCT) measurements. The study will determine whether atom percent enrichment (% APE) at 18 hours can be extrapolated from the steady-state value and whether the mean difference in repeat Ra measurements is below is a prespecified level.

Conditions

Dyslipidemia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

All Subjects

Healthy males

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Subject is male 18 to 45 years of age at screening
• Subject has a stable weight (± 2 kg) for more then 6 weeks prior to screening

Exclusion Criteria

• Subject has a history of ileal bypass, gastric bypass, or other significant condition associated with malabsorption
• Subject has an active or recent (<2 weeks) gastrointestinal condition (gastroenteritis, diarrhea, chronic constipation, irritable bowl syndrome, etc.) affecting bowel movements
• Subject has a known allergy to beans, peas, eggs or egg-derived products and/or soy or soy-derived products
• Subject has a history of plant sterol storage disease (sitosterolemia, cerebrotendinotic xanthomatosis) or a history of intolerance to plant sterols and/or plant sterol containing products
• Subject has a history of hepatic or gall bladder disease (including gallstones, cholecystectomy, etc.)
• Subject is currently taking psyllium, other fiber-based laxatives, phytosterol margarines, and/or over the counter (OTC) therapies that are known to affect serum lipids
• Subject has taken lipid-lowering agents within 6 weeks prior to screening
• Subject has previously been administered an intravenous infusion of [13C3,4]-cholesterol

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

108

Identifier Type: -

Identifier Source: secondary_id

2010_022

Identifier Type: -

Identifier Source: secondary_id

0000-108

Identifier Type: -

Identifier Source: org_study_id