A Safety, Pharmacokinetic, and Pharmacodynamic Assessment of 28-Day Oral Dosing of RVX000222 in Healthy Subjects and Subjects With Low High Density Lipoprotein (HDL)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Safety, pharmacokinetics and changes in lipid parameters from baseline and placebo.
研究概览
简要总结
The purpose of this study is to investigate an oral formulation of RVX000222 for safety, pharmacokinetic and efficacy in healthy subjects.
详细描述
One-third of the US population, almost 80 million adults, have cardiovascular disease and mortality associated with heart disease which still remains a leading cause of death around the world. The major risk factors for cardiovascular disease associated with atherosclerosis is dyslipidemia, characterized by high levels of low density lipoprotein (LDL) and/or low levels of high density lipoprotein (HDL).
HDL has a well established role in atherosclerosis and cardiovascular disease protection. HDL mediates the removal of cholesterol from the atherosclerotic plaques for elimination from the body. The major component of HDL consists of apolipoprotein A-I (ApoA I). Recent intervention studies with synthetic HDL particles and recombinant ApoA-I have shown that HDL has the capacity to reverse coronary atherosclerosis.
RVX000222 is a member of a novel class of small molecules that are candidates for the treatment of dyslipidemia by increasing plasma levels of ApoA-I and HDL.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who meet the following criteria may be enrolled:
- •Be men or women between 18 and 65 years old, inclusive
- •Weigh between 60 kg and 110 kg, inclusive, and have a BMI ≥25 kg/m
- •Healthy volunteers with normal or low HDL
- •If female, non-pregnant (as determined by a negative serum pregnancy test at Screening), non-lactating, and not of childbearing-potential or willing to practice an acceptable form of birth control. If male, be willing to practice an acceptable form of birth control.
排除标准
- •Subjects who meet any of the following criteria will not be enrolled:
- •Have presently, or have a history of, clinically significant disease, including cardiovascular, gastrointestinal, renal, hepatic, pulmonary, endocrine, hematologic, vascular, immunologic, metabolic, neurological, or collagen disease, as judged by the Investigator.
- •Have active cholecystitis or gallbladder symptoms within 60 days prior to Check-in (subjects who have had a cholecystectomy are not excluded from this study).
- •Have had a clinically significant illness, in the opinion of the Investigator, within 30 days prior to Check-in.
- •Have hypertension that is currently being treated, or uncontrolled hypertension
- •Have a serum creatinine >1.5 mg/dL, hemoglobin <11.2 g/dL, or white blood cell count <4000/μL.
- •Have positive test results for HIV, hepatitis A, B, or C.
- •Have a positive result on drug screen testing.
研究组 & 干预措施
Arm A
Low-dose apabetalone (RVX000222) or placebo
干预措施: RVX000222 (Drug)
Arm A
Low-dose apabetalone (RVX000222) or placebo
干预措施: Placebo (Drug)
Arm B
apabetalone (RVX000222) Dose-escalation or placebo
干预措施: RVX000222 (Drug)
Arm B
apabetalone (RVX000222) Dose-escalation or placebo
干预措施: Placebo (Drug)
Arm C
high-dose apabetalone (RVX000222) or placebo
干预措施: RVX000222 (Drug)
Arm C
high-dose apabetalone (RVX000222) or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety, pharmacokinetics and changes in lipid parameters from baseline and placebo.
时间窗: 1-month
次要结局
未报告次要终点