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

Dyslipidemia Clinical Trial

Official title:

A Pilot Study to Evaluate the Plasma Enrichment Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01101763
• Other study ID #: 0000-108
• Secondary ID: 1082010_022
• Status: Completed
• Phase: N/A
• First received: April 8, 2010
• Last updated: April 21, 2015
• Start date: August 2008
• Est. completion date: December 2008

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	%APE (atom percent enrichment) for all study subjects in Part I at 18 hours		18 hours	No
Primary	Rate of appearance (Ra) of unlabeled cholesterol from the whole-body peripheral pool		Baseline and 4 weeks	No