NCT02587416已完成1 期
A Study of the Effect of Oral, Multiple-Dose 300 mg and 900 mg Gemcabene (CI-1027) Administration on the Steady-State Pharmacokinetics of Atorvastatin 80 mg
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
- 20
- 主要终点
- Pharmacokinetics
研究概览
简要总结
The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of atorvastatin 80 mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
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
- •Males and Females
- •18-65 years of age
- •Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements;
- •Body weight 45 kg or greater, with a body mass index (BMI) ≤ 35 kg/m² (weight [kg]/height[meters]²)
排除标准
- •If female, of childbearing potential or lactation
- •History of significant adverse reaction to any lipid-lowering agent
研究组 & 干预措施
Gemcabene 300 mg
Experimental
Gemcabene 300 mg
干预措施: Atorvastatin (Drug)
Gemcabene 300 mg
Experimental
Gemcabene 300 mg
干预措施: Gemcabene 300 mg (Drug)
Gemcabene 900 mg
Experimental
Gemcabene 900 mg
干预措施: Gemcabene 900 mg (Drug)
Gemcabene 900 mg
Experimental
Gemcabene 900 mg
干预措施: Atorvastatin (Drug)
Atorvastatin 80 mg
Active Comparator
Atorvastatin 80 mg
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Pharmacokinetics
时间窗: Days 5, 16, and 27
Area Under the Curve (AUC)
次要结局
- Clinical Laboratory - hematology, chemistry, urinalysis(27 days)
- Adverse Events(27 days)
- ECG(27 days)
研究者
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