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

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.

Completed

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

%APE (atom percent enrichment) for all study subjects in Part I at 18 hours

Time frame: 18 hours
Rate of appearance (Ra) of unlabeled cholesterol from the whole-body peripheral pool

Time frame: Baseline and 4 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Pilot Study to Evaluate the Plasma Enrichment Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Apr 12, 2010
Registry last updated: Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed