A Study of the Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01101763
First received: April 8, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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.


Condition
Dyslipidemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study to Evaluate the Plasma Enrichment Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • %APE (atom percent enrichment) for all study subjects in Part I at 18 hours [ Time Frame: 18 hours ] [ Designated as safety issue: No ]
  • Rate of appearance (Ra) of unlabeled cholesterol from the whole-body peripheral pool [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma


Enrollment: 20
Study Start Date: August 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
All Subjects
Healthy males

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited for the study

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01101763

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01101763     History of Changes
Other Study ID Numbers: 2010_022, 108
Study First Received: April 8, 2010
Last Updated: April 8, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014