NCT01101763已完成不适用
A Pilot Study to Evaluate the Plasma Enrichment Kinetics of a 13C-Cholesterol Infusate in Healthy Male Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- %APE (atom percent enrichment) for all study subjects in Part I at 18 hours
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
%APE (atom percent enrichment) for all study subjects in Part I at 18 hours
时间窗: 18 hours
Rate of appearance (Ra) of unlabeled cholesterol from the whole-body peripheral pool
时间窗: Baseline and 4 weeks
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
Study to Determine and Compare Plasma and Intrapulmonary Concentrations of ETX2514 and Sulbactam in Healthy SubjectsHealthyNCT03303924Entasis Therapeutics30
已完成
1 期
A Study in Healthy Volunteers to Evaluate Serum and Urine Levels of the Investigational Product Versus Comparator.HealthyNCT00280358Dey30
已完成
1 期
An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral AdministrationHealthy ParticipantsNCT06645704Escient Pharmaceuticals, Inc10
已完成
1 期
Mesenchymal Stromal Cells for Degenerative Meniscus InjuryChronic Meniscal InjuryNCT02033525Banc de Sang i Teixits20
已完成
1 期
A Study in Healthy Participants Investigating the Safety, Tolerability and Plasma Pharmacokinetics (PK) of Single Oral Doses of JNJ-47910382Hepatitis C Virus InfectionNCT01482611Janssen R&D Ireland35