NCT04481750

Brief Summary

To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of edaravone solution and suspension in healthy adult males

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
4 years until next milestone

Results Posted

Study results publicly available

August 2, 2024

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

July 17, 2020

Results QC Date

May 12, 2023

Last Update Submit

December 15, 2025

Conditions

Healthy Adult Subjects

Outcome Measures

Primary Outcomes (20)

  • Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs)

    Day 1 to 8 in Part 1, up to 12 days in Part 2

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

    Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of unchanged edaravone.

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

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

    Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of sulfate conjugate.

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

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

    Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of glucuronide conjugate.

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

  • Maximum Plasma Concentration (Cmax) of Unchanged Edaravone

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

  • Maximum Plasma Concentration (Cmax) of Sulfate Conjugate

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

  • Maximum Plasma Concentration (Cmax) of Glucuronide Conjugate

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

  • Part 2: Minimum Plasma Concentration at Steady State (Ctrough, ss)

    Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

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

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

  • Time to Reach Maximum Plasma Concentration (Tmax) of Sulfate Conjugate

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

  • Time to Reach Maximum Plasma Concentration (Tmax) of Glucuronide Conjugate

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

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

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

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

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

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

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

  • Lambda-z of Unchanged Edaravone

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

  • Lambda-z of Sulfate Conjugate

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

  • Lambda-z of Glucuronide Conjugate

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

  • Mean Residence Time (MRT) of Unchanged Edaravone

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

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

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

  • Apparent Distribution Volume at Elimination Phase (Vz/F) and Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone

    Part 1: Pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12, 24, 36, 48 hrs post-dose, Part 2: Day 1 and 5 at pre-dose, 0.25, 0.5, 1.5, 2, 4, 6, 8, 12 hrs post-dose; Day 2 to 4 at pre-dose; Day 6 at 24 hrs post-dose on Day 5; Day 7 at 48 hrs post-dose on Day 5

Secondary Outcomes (4)

  • Change of Heart Rate (HR) From Baseline

    0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.

  • Change of PR Interval (PR) From Baseline

    0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.

  • Change of QTcF Interval (QTcF) From Baseline

    0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.

  • Change of QRS Duration (QRS) From Baseline

    0.75, 0.5, and 0.25 hours pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 36, and 48 hours post-dose.

Study Arms (10)

A single dose MT-1186 (Part 1, Cohort S1)

EXPERIMENTAL

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

Drug: MT-1186Drug: MT-1186-matching placebo

A single dose MT-1186 (Part 1, Cohort S2)

EXPERIMENTAL

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

Drug: MT-1186Drug: MT-1186-matching placebo

A single dose MT-1186 (Part 1, Cohort S3-1)

EXPERIMENTAL

Healthy Japanese male subjects receive doses of MT-1186 or matching placebo.

Drug: MT-1186Drug: MT-1186-matching placebo

A single dose MT-1186 (Part 1, Cohort S3-2)

EXPERIMENTAL

Healthy Japanese male subjects receive doses of MT-1186 or matching placebo.

Drug: MT-1186Drug: MT-1186-matching placebo

A single dose MT-1186 (Part 1, Cohort S4)

EXPERIMENTAL

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

Drug: MT-1186Drug: MT-1186-matching placebo

A single dose MT-1186 (Part 1, Cohort S5)

EXPERIMENTAL

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

Drug: MT-1186Drug: MT-1186-matching placebo

A single dose MT-1186 (Part 1, Cohort S6)

EXPERIMENTAL

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

Drug: MT-1186Drug: MT-1186-matching placebo

A single dose MT-1186 (Part 1, Cohort S7)

EXPERIMENTAL

Healthy Caucasian male subjects receive a single dose of MT-1186 or matching placebo.

Drug: MT-1186Drug: MT-1186-matching placebo

Multiple doses MT-1186 (Part 2, Cohort M1)

EXPERIMENTAL

Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo.

Drug: MT-1186Drug: MT-1186-matching placebo

Multiple doses MT-1186 (Part 2, Cohort M2)

EXPERIMENTAL

Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo

Drug: MT-1186Drug: MT-1186-matching placebo

Interventions

MT-1186DRUG

Solution or suspension

Also known as: Edaravone
A single dose MT-1186 (Part 1, Cohort S1)A single dose MT-1186 (Part 1, Cohort S2)A single dose MT-1186 (Part 1, Cohort S3-1)A single dose MT-1186 (Part 1, Cohort S3-2)A single dose MT-1186 (Part 1, Cohort S4)A single dose MT-1186 (Part 1, Cohort S5)A single dose MT-1186 (Part 1, Cohort S6)A single dose MT-1186 (Part 1, Cohort S7)Multiple doses MT-1186 (Part 2, Cohort M1)Multiple doses MT-1186 (Part 2, Cohort M2)
MT-1186-matching placeboDRUG

Solution or suspension

A single dose MT-1186 (Part 1, Cohort S1)A single dose MT-1186 (Part 1, Cohort S2)A single dose MT-1186 (Part 1, Cohort S3-1)A single dose MT-1186 (Part 1, Cohort S3-2)A single dose MT-1186 (Part 1, Cohort S4)A single dose MT-1186 (Part 1, Cohort S5)A single dose MT-1186 (Part 1, Cohort S6)A single dose MT-1186 (Part 1, Cohort S7)Multiple doses MT-1186 (Part 2, Cohort M1)Multiple doses MT-1186 (Part 2, Cohort M2)

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Additional screening criteria check may apply for qualification:
  • Healthy adult male volunteers
  • Japanese or Caucasian
  • 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:

  • Additional screening criteria check may apply for qualification:
  • 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
  • Body mass index (BMI) of \<18.0 or \>30.0, or body weight of \<50 kg (BMI formula: body weight \[kg\]/height \[m\]2, rounded to one decimal place)
  • Subjects who have undergone any surgery known to affect the gastrointestinal absorption of drugs
  • Subjects who do not agree to use an effective method of contraception from initiation of study drug administration to 14 days after completion (discontinuation) of study drug administration
  • Subjects who have previously received edaravone
  • Subjects who have participated in another clinical study and received a study drug within 12 weeks before providing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site

Osaka, Japan

Location

Related Publications (2)

  • Shimizu H, Nishimura Y, Shiide Y, Matsuda H, Akimoto M, Matsuda M, Nakamaru Y, Kato Y, Kondo K. Evaluation of Pharmacokinetics, Safety, and Drug-Drug Interactions of an Oral Suspension of Edaravone in Healthy Adults. Clin Pharmacol Drug Dev. 2021 Oct;10(10):1174-1187. doi: 10.1002/cpdd.925. Epub 2021 Mar 11.

    PMID: 33704925RESULT

  • 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: 36376130DERIVED

MeSH Terms

Interventions

Edaravone

Intervention Hierarchy (Ancestors)

AntipyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Clinical Trials, Information Desk
Organization
Tanabe Pharma Corporation
cti-inq-ml.JP@ml.tanabe-pharma.com
Please e-mail

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
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single Blind
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 22, 2020

Study Start

March 20, 2018

Primary Completion

August 3, 2018

Study Completion

August 3, 2018

Last Updated

January 7, 2026

Results First Posted

August 2, 2024

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)