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

NCT01101763 | Completed

• 3 other identifiers: 0000-1081082010_022
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• %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

Study Arms (1)

All Subjects

Healthy males

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited for the study

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 12, 2010
• Study Start: August 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 22, 2015

Record last verified: 2015-04