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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01101763
First received: April 8, 2010
Last updated: May 9, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01101763     History of Changes
Other Study ID Numbers: 0000-108, 108, 2010_022
Study First Received: April 8, 2010
Last Updated: May 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 14, 2014