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

Phase 1

Completed

• Conditions: Japanese Patients With ALS
• Interventions: Drug: MT-1186

• Registration Number: NCT04254913
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-23
• Study Start: 2020-01-24
• Study First Submitted QC: 2020-02-02
• Study First Posted: 2020-02-05
• Primary Completion: 2020-04-16
• Study Completion: 2020-04-22
• Status Verified: 2023-04
• Results First Submitted: 2023-04-18
• Results First Submitted QC: 2023-04-18
• Last Update Submitted: 2023-04-18
• Results First Posted: 2024-01-24
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

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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

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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
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.
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 Percentage of Drug Excreted in Urine (Ae) of Edaravone	Urine samples are collected: 0 to 8 hours after oral administration	This information will not be disclosed because it may identify the patient (N=1)
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.
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.
Cumulative Amount of Drug Excreted in Urine (Ae) of Edaravone	Urine samples are collected: 0 to 8 hours after oral administration	This information will not be disclosed because it may identify the patient (N=1).
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 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.
Renal Clearance (CLr) of Edaravone	Urine samples are collected: 0 to 8 hours after oral administration	This information will not be disclosed because it may identify the patient (N=1).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events and Adverse Drug Reactions	The provision of informed consent to Day 8

Trial Locations

Locations (1)

Investigational site; 🇯🇵 Chiba, Japan