Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone
研究概览
简要总结
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic Lateral Sclerosis Patients with gastrostomy
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 80 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 80 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
- •ALS Patients with gastrostomy
- •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 <15.0 or >30.0, or a body weight of <40 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
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone
时间窗: Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration
Cumulative Percentage of Drug Excreted in Urine (Ae) of Edaravone
时间窗: Urine samples are collected: 0 to 8 hours after oral administration
This information will not be disclosed because it may identify the patient (N=1)
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, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.
Cumulative Amount of Drug Excreted in Urine (Ae) of Edaravone
时间窗: Urine samples are collected: 0 to 8 hours after oral administration
This information will not be disclosed because it may identify the patient (N=1).
Maximum Plasma Concentration (Cmax) of Unchanged Edaravone
时间窗: Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.
Apparent Total Clearance (CL/F) of Unchanged Edaravone
时间窗: Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.
Renal Clearance (CLr) of Edaravone
时间窗: Urine samples are collected: 0 to 8 hours after oral administration
This information will not be disclosed because it may identify the patient (N=1).
次要结局
- Number of Participants With Adverse Events and Adverse Drug Reactions(The provision of informed consent to Day 8)