Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study)

NCT05342597 | Completed Phase 1 Results FDA Drug

• 1 other identifier: MT-1186-J06
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of food on the pharmacokinetics of oral edaravone in healthy adult subjects. In this study, we determined 5 different dietary conditions including 4 different meal contents and fasting condition.

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (14)

• Area Under the Concentration Versus Time Curve From Zero up to Infinity (AUC0-inf) of Edaravone

  Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

• Maximum Plasma Concentration (Cmax) of Edaravone

  Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

• AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate

  Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

• Cmax of Sulfate Conjugate and Glucuronide Conjugate

  Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

• Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate

  Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

• Terminal Elimination Half-life (t1/2) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate

  Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

• Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate

  Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

• Mean Residence Time (MRT) of Unchanged Edaravone

  Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

• Apparent Total Clearance (CL/F) of Unchanged Edaravone

  Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

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

  Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

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

  Before administration, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours after administration

• Cumulative Urinary Excretion Amount (Ae 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate

  Day 1 to 9, Day 24 to 26

• Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate

  Day 1 to 9, Day 24 to 26

• Renal Clearance (CLr) of Unchanged Edaravone

  Day 1 to 9, Day 24 to 26

Secondary Outcomes (1)

• Number of Participants With Adverse Events and Adverse Drug Reactions

  Day 1 to Day 31

Study Arms (4)

Group A

EXPERIMENTAL

A single oral dose of MT-1186 with fasted condition in period 1, meal 1 condition in period 2, meal 2 condition in period 3, meal 3 condition in period 4, and meal 4 condition in period 5.

Drug: MT-1186

Group B

EXPERIMENTAL

A single oral dose of MT-1186 with meal 1 condition in period 1, meal 2 condition in period 2, meal 3 condition in period 3, fasted condition in period 4, and meal 4 condition in period 5.

Drug: MT-1186

Group C

EXPERIMENTAL

A single oral dose of MT-1186 with meal 2 condition in period 1, meal 3 condition in period 2, fasted condition in period 3, meal 1 condition in period 4, and meal 4 condition in period 5.

Drug: MT-1186

Group D

EXPERIMENTAL

A single oral dose of MT-1186 with meal 3 condition in period 1, fasted condition in period 2, meal 1 condition in period 3, meal 2 in period 4, and meal 4 condition in period 5.

Drug: MT-1186

Interventions

MT-1186 DRUG

A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence.

Also known as: Edaravone

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who meet all of the following criteria and who have the capability of giving informed consent will be included in the study.
• Healthy adult male or female volunteers
• Japanese
• Subjects aged between 20 and 45 years at the time of informed consent
• Subjects who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study

You may not qualify if:

• Subjects with a current or previous history of cardiac, hepatic, renal, gastrointestinal, respiratory, psychiatric/nervous, hematopoietic, or endocrine diseases, and those whom the investigator (or subinvestigator) deems unsuitable for the study
• History of drug or food allergies
• History of alcohol or drug abuse or dependence
• Body mass index (BMI) of \< 18.0 or \> 30.0, or a body weight of \< 50 kg \[BMI formula: body weight (kg)/height (m)2, rounded to one decimal place\]
• Positive test for any of the following at screening: hepatitis B surface (HBs) antigen, serological test for syphilis, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody
• Any clinically significant 12-lead ECG abnormality or corrected QT interval (QTc) using Fridericia's formula (QTcF) interval ≥ 450 msec
• Blood donation or sampling with a total volume of ≥ 400 mL within 12 weeks, ≥ 200 mL within 4 weeks, or ≥ 800 mL within one year before providing informed consent
• Blood component donation or blood sampling within 2 weeks before providing informed consent
• Subjects who have undergone any surgery known to affect the gastrointestinal absorption of drugs (except for appendectomy and herniotomy)
• Female subjects who do not agree to use an effective method of contraception from screening or 2 weeks before the start of investigational product administration, whichever comes earlier, to 14 days after the completion (or discontinuation) of investigational product administration. Male subjects who do not agree to use an effective method of contraception from the start of investigational product administration to 14 days after the completion (or discontinuation) of investigational product administration
• Subjects who have previously received edaravone
• Subjects who have participated in another clinical study and received an investigational product within 12 weeks before providing informed consent
• Subjects who have used any drugs other than the single use of acetylsalicylic acid within 7 days before the initiation of investigational product administration
• Use of any nutritional supplement(s) within 7 days before the initiation of investigational product administration
• Use of alcohol or any products containing xanthin or caffeine within 24 hours before screening and visit on Day -1

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational site

Tokyo, Japan

Location

Related Publications (1)

• Shimizu H, Nishimura Y, Shiide Y, Akimoto M, Matsuda H, Kato Y, Hirai M. Food Effect Study to Assess the Impact on Edaravone Pharmacokinetic Profiles in Healthy Participants. Clin Ther. 2022 Dec;44(12):1552-1565. doi: 10.1016/j.clinthera.2022.10.001. Epub 2022 Nov 12.

  PMID: 36376130 RESULT

MeSH Terms

Interventions

Edaravone

Intervention Hierarchy (Ancestors)

Antipyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Please email

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2022
• First Posted: April 22, 2022
• Study Start: June 10, 2019
• Primary Completion: July 24, 2019
• Study Completion: July 24, 2019
• Last Updated: January 7, 2026
• Results First Posted: January 5, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)