Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube

NCT04776135 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: MT-1186-Z-101jRCT2031200361
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the comparative bioavailability of edaravone oral suspension administered orally and via a nasogastric tube in healthy adult subjects

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (9)

• Area Under the Concentration Versus Time Curve (AUC) of Edaravone

  Area under the plasma concentration versus time curve from time zero up to the last quantifiable concentration time-point (AUC0-t) of edaravone, and Area under the plasma concentration versus time curve from time zero up to infinity with extrapolation of the terminal phase (AUC0-inf) of edaravone.

  Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hours after administration.

• Maximum Plasma Concentration (Cmax) of Edaravone

  Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.

• Time to Reach Maximum Plasma Concentration (Tmax) of Edaravone

  Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.

• Terminal Elimination Half-life (t1/2) of Edaravone

  Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.

• Apparent Terminal Elimination Rate Constant (Kel) of Edaravone

  Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.

• Mean Residence Time (MRT) of Edaravone

  Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.

• Apparent Total Clearance (CL/F) of Edaravone

  Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.

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

  Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.

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

  Plasma samples are collected: Day 1 and Day 4 at pre-dose, 0.083, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8, 10, and 12 hours; Day 2 and Day 5 at 24 and 36 hours; Day 3 and Day 6 at 48 hour after administration.

Secondary Outcomes (1)

• Number of Participants With Adverse Events and Adverse Drug Reactions

  Day 1 to 11

Study Arms (2)

MT-1186 orally

EXPERIMENTAL

Subjects receive the edaravone oral suspension orally.

Drug: MT-1186

MT-1186 via a nasogastric tube

EXPERIMENTAL

Subjects receive the edaravone oral suspension via a nasogastric tube

Drug: MT-1186

Interventions

MT-1186 DRUG

Suspension

Also known as: Edaravone

MT-1186 orally; MT-1186 via a nasogastric tube

Eligibility Criteria

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

You may qualify if:

• 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 antigen, serological test for syphilis, hepatitis C virus antibody, or human immunodeficiency virus antigen/antibody, subject has a positive COVID-19 virus test on Day -1
• Any clinically significant 12-lead ECG abnormality or 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, or blood donation and transfusion from informed consent to the start of investigational product administration
• Subjects who have undergone any surgery known to affect the gastrointestinal absorption of drugs (except for appendectomy and herniotomy)
• Female subjects of childbearing potential 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 alcohol or any products containing xanthin or caffeine within 24 hours before screening and visit on Day -1
• Use of any nutritional supplement(s) within 7 days before the initiation of investigational product administration

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational site

Tokyo, Toshima-ku, 171-0014, Japan

Location

Related Publications (1)

• Shimizu H, Nishimura Y, Shiide Y, Ueda M, Yokota S, Kato Y, Hirai M. Edaravone Administered Orally and Via Nasogastric Tube in Healthy Adults: A Comparative Bioavailability Phase 1 Study. Clin Pharmacol Drug Dev. 2023 Jan;12(1):77-84. doi: 10.1002/cpdd.1175. Epub 2022 Oct 12.

  PMID: 36225132 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: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: February 26, 2021
• Primary Completion: April 1, 2021
• Study Completion: April 16, 2021
• Last Updated: January 7, 2026
• Results First Posted: January 8, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)