NCT03757351终止1 期
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL747 in Subjects With Amyotrophic Lateral Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of DNL747 in subjects with Amyotrophic Lateral Sclerosis in a cross-over design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Open-Label Extension
Experimental
Conducted in the Netherlands only.
干预措施: DNL747 (Drug)
DNL747 First, Placebo Second
Experimental
干预措施: DNL747 (Drug)
DNL747 First, Placebo Second
Experimental
干预措施: Placebo (Drug)
Placebo First, DNL747 Second
Experimental
干预措施: DNL747 (Drug)
Placebo First, DNL747 Second
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Randomization - Day 86
Number of Subjects with clinically significant neurological examination abnormalities
时间窗: Randomization - Day 86
Number of Subjects with laboratory test abnormalities
时间窗: Randomization - Day 86
次要结局
- Pharmacokinetic measure of maximum observed plasma concentration (Cmax) of DNL747(Randomization - Day 86)
- Pharmacokinetic measure of time to reach maximum observed plasma concentration (Tmax) of DNL747(Randomization - Day 86)
- Pharmacokinetic measure of area under the plasma drug concentration-time curve (AUC) of DNL747(Randomization - Day 86)
- Pharmacokinetic terminal disposition rate constant (λz) with the respective t1/2 of DNL747(Randomization - Day 86)
- Pharmacokinetic measure of CSF concentrations of DNL747(Randomization - Day 86)
- Pharmacodynamic measure of pS166 in PBMCs(Randomization - Day 86)
研究者
研究点 (3)
Loading locations...
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