NCT02576639已完成2 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of CNP520 in Healthy Elderly Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths
研究概览
简要总结
The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in subsequent efficacy studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy status
- •Body weight: ≥45kg
- •BMI: 18-34 kg/m2
排除标准
- •History or presence of any clinically significant disease of any major system organ class.
- •Heavy smoker status
- •History /presence of clinically significant neurological or psychiatric disorders
- •Any medical condition that might lead to or is associated with any cognitive deficit
- •History or presence of severely impaired renal function
研究组 & 干预措施
Placebo
Placebo Comparator
Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
干预措施: Placebo (Drug)
CNP520 2 mg
Experimental
CNP520 2 mg was taken qd orally for 13 weeks.
干预措施: CNP520 (Drug)
CNP520 10 mg
Experimental
CNP520 10 mg was taken qd orally for 13 weeks.
干预措施: CNP520 (Drug)
CNP520 35 mg
Experimental
CNP520 35 mg was taken qd orally for 13 weeks.
干预措施: CNP520 (Drug)
CNP520 85 mg
Experimental
CNP520 85 mg was taken qd orally for 13 weeks.
干预措施: CNP520 (Drug)
结局指标
主要结局
Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths
时间窗: 13 weeks
Safety monitoring was conducted throughout the study.
次要结局
- Summary of PK Parameter: CLss/F(Day 91)
- Summary of Plasma PK Parameter: Racc(Day 91)
- Summary of CSF PK Concentrations(Days 1, 14, 28, 42, 56, 70 and 91)
- Apparent Volume of Distribution (Vz/F)(Day 91)
- Summary of Plasma PK Parameter: Cmax(Days 1, 91)
- Summary of Plasma PK Parameter: Tlag(Days 1 and 91)
- Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations(Day 92)
- Summary of Plasma PK Parameter: AUCtau(Days 1 and 91)
- Summary of Plasma PK Parameter: Tmax(Days 1 and 91)
- Summary of Plasma PK Parameter: T1/2(Day 91)
- Area-under-plasma Concentration Time Curve up to Infinity (AUCinf)(Day 91)
研究者
研究点 (1)
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