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

NCT04254913 | Completed Phase 1 Results

• 1 other identifier: MT-1186-J05
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Japanese Patients With ALS

Outcome Measures

Primary Outcomes (12)

• 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, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.

• Maximum Plasma Concentration (Cmax) of Unchanged Edaravone

  Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 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, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.

• Terminal Elimination Half-life (t1/2) of Unchanged Edaravone

  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

  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

  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

  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

  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

  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

  This information will not be disclosed because it may identify the patient (N=1).

  Urine samples are collected: 0 to 8 hours after oral administration

• Cumulative Percentage of Drug Excreted in Urine (Ae) of Edaravone

  This information will not be disclosed because it may identify the patient (N=1)

  Urine samples are collected: 0 to 8 hours after oral administration

• Renal Clearance (CLr) of Edaravone

  This information will not be disclosed because it may identify the patient (N=1).

  Urine samples are collected: 0 to 8 hours after oral administration

Secondary Outcomes (1)

• Number of Participants With Adverse Events and Adverse Drug Reactions

  The provision of informed consent to Day 8

Study Arms (1)

MT-1186

EXPERIMENTAL

Patients receive the edaravone oral suspension.

Drug: MT-1186

Interventions

MT-1186 DRUG

Suspension

Also known as: Edaravone

MT-1186

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational site

Chiba, Japan

Location

Related Publications (1)

• Shimizu H, Nishimura Y, Shiide Y, Akimoto M, Yashiro M, Ueda M, Hirai M, Yoshino H, Mizutani T, Kanai K, Kano O, Kimura H, Sekino H, Ito K. Pharmacokinetics of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis. Clin Ther. 2023 Dec;45(12):1251-1258. doi: 10.1016/j.clinthera.2023.09.025. Epub 2023 Nov 11.

  PMID: 37953075 DERIVED

MeSH Terms

Interventions

Edaravone

Intervention Hierarchy (Ancestors)

Antipyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Please email

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: February 5, 2020
• Study Start: January 24, 2020
• Primary Completion: April 16, 2020
• Study Completion: April 22, 2020
• Last Updated: January 7, 2026
• Results First Posted: January 24, 2024

Record last verified: 2025-12

Locations

JP (1)