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

Japanese Patients With ALS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254913
• Other study ID #: MT-1186-J05
• Status: Completed
• Phase: Phase 1
• Start date: January 24, 2020
• Est. completion date: April 22, 2020

Study information

• Verified date: April 2023
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 22, 2020
• Est. primary completion date: April 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Japanese Patients With ALS
• Motor Neuron Disease

Intervention

Drug:
• MT-1186
Suspension

Locations

Country	Name	City	State
Japan	Investigational site	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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	Number of Participants With Adverse Events and Adverse Drug Reactions		The provision of informed consent to Day 8