Clinical trial

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

ID

Name

MT-1186-J04

Description

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

Trial arms

Trial start

2019-04-17

Estimated PCD

2019-09-04

Trial end

2019-09-04

Status

Completed

Phase

Early phase I

Treatment

MT-1186

Suspension

Arms:

MT-1186

Other names:

Edaravone

Size

9

Primary endpoint

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.

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.

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.

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 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 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.

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 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

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

Renal Clearance (CLr) of Unchanged Edaravone

Urine samples are collected: 0 to 24 hours after oral administration

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 9, 'type': 'ACTUAL'}}

Updated at

2024-01-24

1 organization

1 product

1 indication

Organization

Mitsubishi Tanabe Pharma

Product

Indication

Amyotrophic Lateral Sclerosis