NCT01146522已完成1 期
A Multiple-dose, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCQ908 in Patients With Severe Hypertriglyceridemia and Chylomicronemia (Phenotypes I and V)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Fasting and postprandial plasma triglycerides
研究概览
简要总结
This study will assess safety, tolerability, and effect of LCQ908 on blood lipids in patients with severe hypertriglyceridemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hyperlipoproteinemia Type I or Type V willing and medically able to discontinue their lipid lowering medication (if prescribed).
- •Non breast feeding women.
- •Women of child bearing potential practicing appropriate contraception with a negative pregnancy test before dosing.
排除标准
- •Patients with:
- •uncontrolled type 1 or type 2 diabetes mellitus,
- •active pancreatitis (the month prior to study start),
- •history of drug or alcohol abuse within the 12 months prior to dosing,
- •or any surgical or medical condition, acute or unstable chronic disease which may, based on the investigator's opinion, jeopardize the patient in case of participation in the study.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
LCQ908
Experimental
干预措施: LCQ908 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Fasting and postprandial plasma triglycerides
时间窗: baseline and 3 weeks after initiation of each dose level (a test meal will be served at baseline and on Day 21 of treatment)
次要结局
- Blood concentration to characterize LCQ908 kinetics(serial blood samples will be collected from all patients enrolled in the study on Day 21 of treatment with each dose)
- Different blood lipid biomarkers (such as phospholipids, apolipoproteins, and free fatty acids)(after 3 weeks of treatment with each dose)
研究者
研究点 (1)
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