JPRN-jRCT2080225036已完成1 期
Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis (ALS) Patients with Percutaneous Endoscopic Gastrostomy (PEG)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
In 6 subjects with ALS, edaravone was well absorbed after administration of edaravone oral suspension via a PEG tube with tmax of 0.25-0.50 hours. The mean Cmax and AUC0-inf of unchanged edaravone after oral administration of 105 mg edaravone were 2163 ng/mL and 2310 ng*h/mL, respectively. The edaravone was mainly eliminated into urine as glucuronide conjugate and subdominantly as sulfate conjugate after oral administration via a PEG tube. There were no safety concerns in the results of this study.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •The key criteria are listed below.
- •1. Patients aged between 20 and 80 years at the time of informed consent
- •2. Japanese patients
- •3. 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
- •4. ALS Patients with gastrostomy
- •5. Patients who can consent to contraception
- •6. 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.
- •1. 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
- •2. Patients undergoing treatment for malignancy.
- •3. 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
- •4. Body mass index (BMI) of <15.0 or >30.0, or a body weight of <40 kg
- •5. Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason
研究者
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