A Site and Subject Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS 852927 in Patients With Primary Hypercholesterolemia on a Stable Dose of Statin Therapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy
研究概览
简要总结
The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in patients with high cholesterol.
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
- •Men and women, aged ≥18 to ≤75
- •Body mass index (BMI) ≤ 40 kg/m2
- •Primary hypercholesterolemia on a stable daily dose of a statin for ≥ 6 weeks
- •Serum triglyceride levels at screening < 400mg/dL (< 4.52 mmol/L)
排除标准
- •Any significant acute medical illness, significant cardiovascular history
- •Current or history of hepatic or hepatobiliary disease
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
研究组 & 干预措施
Arm 1: BMS-852927 (0.25 mg)
干预措施: BMS-852927 (Drug)
Arm 2: BMS-852927 (1.0 mg)
干预措施: BMS-852927 (Drug)
Arm 3: BMS-852927 (2.5 mg)
干预措施: BMS-852927 (Drug)
Arm 4: Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy
时间窗: Up to 30 days post discontinuation of dosing or last participation in the study for serious adverse events collection
Number and percent of subjects with potentially clinically significant changes in ECG parameter
时间窗: Upto 56 days
Electrocardiogram (ECG) parameters defined as: * Investigator identified clinically significant abnormalities * QTcF\> 480 msec or QTcF changes from baseline\> 60 msec * QRS (msec): QRS\> 120 msec * PR (msec): PR \> 210 msec
Number and percent of subjects with potentially clinically significant changes in low density lipoprotein (LDL)-c (measured)
时间窗: Upto 56 days
LDL-c (measured) defined as: * LDL-c (mg/dL): LDL-c percent changes from baseline \>= 15%
次要结局
- Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data(Days 7, 14, 21 and 28)
- Area under the concentration-time curve from zero (pre-dose) to 8 h [AUC(0-8h)] of BMS-852927 will be derived from plasma concentration versus time data(Days 1 and 28)