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Completed

NCT Number: NCT04254913

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

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Key information

Conditions

Japanese Patients With ALS

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational site

Chiba, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-1186

Drug

Suspension

Other names: Edaravone

Primary outcomes

  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

    Time frame: 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.

  2. Maximum Plasma Concentration (Cmax) of Unchanged Edaravone

    Time frame: 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.

  3. Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone

    Time frame: 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.

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

    Time frame: 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.

  5. Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone

    Time frame: 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.

  6. Mean Residence Time (MRT) of Unchanged Edaravone

    Time frame: 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.

  7. Apparent Total Clearance (CL/F) of Unchanged Edaravone

    Time frame: 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.

  8. Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone

    Time frame: 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.

  9. Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone

    Time frame: 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

  10. Cumulative Amount of Drug Excreted in Urine (Ae) of Edaravone

    Time frame: 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).

  11. Cumulative Percentage of Drug Excreted in Urine (Ae) of Edaravone

    Time frame: 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)

  12. Renal Clearance (CLr) of Edaravone

    Time frame: 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 outcomes

  1. Number of Participants With Adverse Events and Adverse Drug Reactions

    Time frame: The provision of informed consent to Day 8

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 5, 2020
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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