Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Cumulative Amount of Drug Excreted in Urine From Time Zero up to 24 Hours (Ae0-24) of Unchanged Edaravone
研究概览
简要总结
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients with Amyotrophic Lateral Sclerosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The key criteria are listed below.
- •Patients aged between 20 and 75 years at the time of informed consent
- •Japanese patients
- •Among patients with ALS, those "Clinically definite ALS," "Clinically probable ALS" or "Clinically probable-laboratory-supported ALS" according to El Escorial Revised Airlie House criteria
- •Patients who can consent to contraception
- •Patients who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study
排除标准
- •The key criteria are listed below.
- •Patients in whom the possibility could not be ruled out that the current symptoms were symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy
- •Patients undergoing treatment for malignancy
- •Patients who have presence of clinically significant liver, heart, or renal disease requiring hospitalization (except ALS) and infections requiring antibiotics. Patients who have a problem in general condition and are judged ineligible by the Investigator
- •Body mass index (BMI) of <18.0 or >30.0, or a body weight of <50 kg
- •Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason
研究组 & 干预措施
MT-1186
Patients receive the edaravone oral suspension.
干预措施: MT-1186 (Drug)
结局指标
主要结局
Cumulative Amount of Drug Excreted in Urine From Time Zero up to 24 Hours (Ae0-24) of Unchanged Edaravone
时间窗: Urine samples are collected: 0 to 24 hours after oral administration
Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone
时间窗: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.
Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone
时间窗: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.
Maximum Plasma Concentration (Cmax) of Unchanged Edaravone
时间窗: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone
时间窗: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.
Terminal Elimination Half-life (t1/2) of Unchanged Edaravone
时间窗: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.
Mean Residence Time (MRT) of Unchanged Edaravone
时间窗: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone
时间窗: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.
Renal Clearance (CLr) of Unchanged Edaravone
时间窗: Urine samples are collected: 0 to 24 hours after oral administration
Apparent Total Clearance (CL/F) of Unchanged Edaravone
时间窗: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.
Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone
时间窗: Plasma samples are collected: Day 1 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 at 24 hours after administration.
Cumulative Percentage of Drug Excreted in Urine From Time Zero up to 24 Hours (Ae0-24) of Unchanged Edaravone
时间窗: Urine samples are collected: 0 to 24 hours after oral administration
次要结局
- Number of Participants With Adverse Events and Adverse Drug Reactions(Day 1 to 8)