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

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

Study Overview

• Status: Completed
• Conditions: Japanese Patients With ALS
• Intervention / Treatment: Drug: MT-1186

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan
    • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MT-1186; Patients receive the edaravone oral suspension.	Drug: MT-1186; Suspension; Other Names: Edaravone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Adverse Events and Adverse Drug Reactions	The provision of informed consent to Day 8

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation
• Investigators: Study Director: General Manager, Mitsubishi Tanabe Pharma Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2020
• Primary Completion (Actual): April 16, 2020
• Study Completion (Actual): April 22, 2020

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: February 2, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neuroprotective Agents; Protective Agents; Antioxidants; Free Radical Scavengers; Edaravone
• Other Study ID Numbers: MT-1186-J05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No