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

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ClinicalTrials.gov Identifier: NCT01101763
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease
Dyslipidemia

Study Type : Observational
Actual Enrollment : 20 participants
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
Study Start Date : August 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Group/Cohort
All Subjects
Healthy males



Primary Outcome Measures :
  1. %APE (atom percent enrichment) for all study subjects in Part I at 18 hours [ Time Frame: 18 hours ]
  2. Rate of appearance (Ra) of unlabeled cholesterol from the whole-body peripheral pool [ Time Frame: Baseline and 4 weeks ]

Biospecimen Retention:   Samples Without DNA
Plasma


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101763


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01101763     History of Changes
Other Study ID Numbers: 0000-108
108
2010_022
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases