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

Phase 1

Completed

Conditions: Japanese Patients With ALS

Interventions: Drug: MT-1186

Registration Number: NCT04176224

Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 9

Inclusion Criteria

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

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 <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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MT-1186	MT-1186	Patients receive the edaravone oral suspension.

Primary Outcome Measures

Name	Time	Method
Cumulative Amount of Drug Excreted in Urine From Time Zero up to 24 Hours (Ae0-24) of Unchanged Edaravone	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	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	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	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	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	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	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	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	Urine samples are collected: 0 to 24 hours after oral administration
Apparent Total Clearance (CL/F) of Unchanged Edaravone	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	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	Urine samples are collected: 0 to 24 hours after oral administration