Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy

Study Overview
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Brief Summary
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To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic Lateral Sclerosis Patients with gastrostomy

Official Title
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Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy

Conditions
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Japanese Patients With ALS

Intervention / Treatment
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* Drug: MT-1186


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-1186<br>Patients receive the edaravone oral suspension. | Drug: MT-1186<br>* Suspension<br>* Other names: Edaravone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of edaravone |  | Day 1 to 2 | 
| Urine concentrations of edaravone |  | Day 1 | 
| Area under the concentration versus time curve (AUC) of edaravone |  | Day 1 to 2 | 
| Maximum plasma concentration (Cmax) of edaravone |  | Day 1 to 2 | 
| Time to reach maximum plasma concentration (tmax) of edaravone |  | Day 1 to 2 | 
| Terminal elimination half-life (t1/2) of edaravone |  | Day 1 to 2 | 
| Apparent terminal elimination rate constant (Kel) of edaravone |  | Day 1 to 2 | 
| Mean residence time (MRT) of edaravone |  | Day 1 to 2 | 
| Apparent total clearance (CL/F) of edaravone |  | Day 1 to 2 | 
| Apparent distribution volume at elimination phase (Vz/F) of edaravone |  | Day 1 to 2 | 
| Apparent distribution volume at steady state (Vss/F) of edaravone |  | Day 1 to 2 | 
| Cumulative amount of drug excreted in urine (Ae) of edaravone |  | Day 1 to 2 | 
| Cumulative percentage of drug excreted in urine (Ae%) of edaravone |  | Day 1 to 2 | 
| Apparent renal clearance (CLr/F) of edaravone |  | Day 1 to 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse events and adverse drug reactions |  | The provision of informed consent to Day 8 |