A Study of the Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01101763
First received: April 8, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
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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:
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 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 May 21, 2013