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

Completed

• Conditions: Dyslipidemia

• Registration Number: NCT01101763
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-11
• Study Completion: 2008-12
• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
%APE (atom percent enrichment) for all study subjects in Part I at 18 hours	18 hours
Rate of appearance (Ra) of unlabeled cholesterol from the whole-body peripheral pool	Baseline and 4 weeks