Healthy Adult SubjectsPhase 1NCT04481750

Study of Oral Edaravone in Healthy Adult Males

A Phase 1 study testing MT-1186 in people with Healthy Adult Subjects, run by Shionogi at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of edaravone solution and suspension in healthy adult males Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Adult Subjects
What is being tested?: MT-1186
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 1 siteJapan
Study dates: 20 Mar 2018to 3 Aug 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Investigational Site
Osaka

Other trials in Japan

About this study

Official title: Phase I Study of Oral Edaravone in Healthy Adult Males (Single- and Multiple-dose Study)

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

Conditions: Healthy Adult Subjects
Being tested: MT-1186, MT-1186-matching placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MT-1186Drug
Also called Edaravone
Solution or suspension
MT-1186-matching placeboDrug
Solution or suspension

Study groups in NCT04481750
Study group	Role	What they receive
A single dose MT-1186 (Part 1, Cohort S1)	Experimental	Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo. Receives: Drug: MT-1186; Drug: 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. Receives: Drug: MT-1186; Drug: 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. Receives: Drug: MT-1186; Drug: 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. Receives: Drug: MT-1186; Drug: 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. Receives: Drug: MT-1186; Drug: 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. Receives: Drug: MT-1186; Drug: 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. Receives: Drug: MT-1186; Drug: 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. Receives: Drug: MT-1186; Drug: 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. Receives: Drug: MT-1186; Drug: 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 Receives: Drug: MT-1186; Drug: MT-1186-matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose.
Measured: 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
Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose.
Measured: 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
Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6. Baseline is calculated as average HR from 0.75, 0.5, and 0.25 hours pre-dose.
Measured: 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
Holter ECG data were recorded in part 1, Cohorts S4, S5, and S6.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 20183 Aug 2018

First posted22 Jul 2020
Study start20 Mar 2018
Primary completion3 Aug 2018
Study completion3 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Healthy Adult SubjectsStudies of the same condition, open and under way.
More trials run by ShionogiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04481750
Sponsor's protocol ID: MT-1186-J01
Status last verified: Jun 2026
First submitted: 17 Jul 2020
Last updated: 16 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 33704925
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.
PubMed 36376130

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Study of Oral Edaravone in Healthy Adult Males (Single- and Multiple-dose Study)
ClinicalTrials.gov ID: NCT04481750
Acronym / sponsor ID: MT-1186-J01
Conditions: Healthy Adult Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Study start: 20 Mar 2018 (actual)
Primary completion: 3 Aug 2018 (actual)
Study completion: 3 Aug 2018 (actual)
First posted: 22 Jul 2020 (actual)
Results: Posted 2 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 10

Arm	Type	Receives
A single dose MT-1186 (Part 1, Cohort S1)	Experimental	Drug: MT-1186, Drug: MT-1186-matching placeboHealthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.
A single dose MT-1186 (Part 1, Cohort S2)	Experimental	Drug: MT-1186, Drug: MT-1186-matching placeboHealthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.
A single dose MT-1186 (Part 1, Cohort S3-1)	Experimental	Drug: MT-1186, Drug: MT-1186-matching placeboHealthy Japanese male subjects receive doses of MT-1186 or matching placebo.
A single dose MT-1186 (Part 1, Cohort S3-2)	Experimental	Drug: MT-1186, Drug: MT-1186-matching placeboHealthy Japanese male subjects receive doses of MT-1186 or matching placebo.
A single dose MT-1186 (Part 1, Cohort S4)	Experimental	Drug: MT-1186, Drug: MT-1186-matching placeboHealthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.
A single dose MT-1186 (Part 1, Cohort S5)	Experimental	Drug: MT-1186, Drug: MT-1186-matching placeboHealthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.
A single dose MT-1186 (Part 1, Cohort S6)	Experimental	Drug: MT-1186, Drug: MT-1186-matching placeboHealthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.
A single dose MT-1186 (Part 1, Cohort S7)	Experimental	Drug: MT-1186, Drug: MT-1186-matching placeboHealthy Caucasian male subjects receive a single dose of MT-1186 or matching placebo.
Multiple doses MT-1186 (Part 2, Cohort M1)	Experimental	Drug: MT-1186, Drug: MT-1186-matching placeboHealthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo.
Multiple doses MT-1186 (Part 2, Cohort M2)	Experimental	Drug: MT-1186, Drug: MT-1186-matching placeboHealthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MT-1186Also: EdaravoneSolution or suspension	Drug	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 placeboSolution or suspension	Drug	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)

Primary outcome

Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs)
Time frame: 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
Time frame: 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 plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of unchanged edaravone.
Area Under the Concentration Versus Time Curve (AUC) of Sulfate Conjugate
Time frame: 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 plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of sulfate conjugate.
Area Under the Concentration Versus Time Curve (AUC) of Glucuronide Conjugate
Time frame: 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 plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of glucuronide conjugate.
Maximum Plasma Concentration (Cmax) of Unchanged Edaravone
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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

4 secondary outcomes

Change of Heart Rate (HR) From Baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 2 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A Single Dose MT-1186 (Part 1, Cohort S1)	6	6
A Single Dose MT-1186 (Part 1, Cohort S2)	6	6
A Single Dose MT-1186 (Part 1, Cohort S3)	6	5
A Single Dose MT-1186 (Part 1, Cohort S4)	6	6
A Single Dose MT-1186 (Part 1, Cohort S5)	6	6
A Single Dose MT-1186 (Part 1, Cohort S6)	6	6
A Single Dose MT-1186 (Part 1, Cohort S7)	6	6
Matching Placebo (a Single Dose Cohorts)	14	14
Multiple Doses MT-1186 (Part 2, Cohort M1)	6	6
Multiple Doses MT-1186 (Part 2, Cohort M2)	6	6
Matching Placebo (Multiple Doses Cohorts)	6	6

Primary outcome: Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs)

Time frame: Day 1 to 8 in Part 1, up to 12 days in Part 2. Count of participants. Unit: Participants

Measure	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1) n = 6	A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2) n = 5	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7) n = 6	Matching Placebo Under Fasted Condition (a Sngle Dose Cohorts) n = 14	Multiple Doses MT-1186 (Part 2, Cohort M1) n = 6	Multiple Doses MT-1186 (Part 2, Cohort M2) n = 6	Matching Placebo (Multiple Doses Cohorts) n = 6
Participants with AEs	0	2	3	0	0	1	1	2	2	2	1	1
Participants with ADRs	0	0	0	0	0	0	0	1	0	0	0	0

Population analysed: The trial is divided into 2 phases (a single and multiple-dose). A single-dose study included 8 cohorts (total of 56 subjects), with 42 (6x7) subjects receiving MT-1186, and 14 (2x7) receiving the placebo. Multiple-dose study included 2 cohorts (total of 18 subjects), with 12 (6x2) receiving MT-1186, and 6 (3x2) receiving the placebo for 5 days. Since Cohort S3-1 and S3-2 are crossover cohort, the 5 subjects in Cohort S3-2 are overlapped (total of 79 subjects).

Primary outcome: Area Under the Concentration Versus Time Curve (AUC) of Unchanged Edaravone

Time frame: 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 (Standard Deviation). Unit: ng*h/mL

Measure	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1) n = 6	A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2) n = 5	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7) n = 6	Multiple Doses MT-1186 (Part 2, Cohort M1) n = 6	Multiple Doses MT-1186 (Part 2, Cohort M2) n = 6
AUC from time zero to 24 hour (AUC 0-24): Day 1	816 (231)	2242 (911)	6254 (1236)	2443 (813)	11319 (1053)	9034 (2738)	285 (113)	4935 (1980)	1917 (383)	4133 (1260)
AUC from time zero to 24 hour (AUC 0-24): Day 5, only Part 2	–	–	–	–	–	–	–	–	2189 (516)	4279 (1166)

Primary outcome: Area Under the Concentration Versus Time Curve (AUC) of Sulfate Conjugate

Measure	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1) n = 6	A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2) n = 5	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7) n = 6	Multiple Doses MT-1186 (Part 2, Cohort M1) n = 6	Multiple Doses MT-1186 (Part 2, Cohort M2) n = 6
AUC from time zero to 24 hour (AUC 0-24): Day 1	16251 (7143)	30004 (6103)	45666 (10447)	38244 (4602)	67693 (14170)	68126 (15067)	6709 (2171)	44797 (16374)	26132 (4083)	39516 (3331)
AUC from time zero to 24 hour (AUC 0-24): Day 5, only part 2	–	–	–	–	–	–	–	–	24578 (4186)	39102 (4208)

Primary outcome: Area Under the Concentration Versus Time Curve (AUC) of Glucuronide Conjugate

Measure	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S1) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S2) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S3-1) n = 6	A Single Dose MT-1186 Under Fed Condition(Part 1, Cohort S3-2) n = 5	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S4) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S5) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S6) n = 6	A Single Dose MT-1186 Under Fasted Condition (Part 1, Cohort S7) n = 6	Multiple Doses MT-1186 (Part 2, Cohort M1) n = 6	Multiple Doses MT-1186 (Part 2, Cohort M2) n = 6
AUC from time zero to 24 hour (AUC 0-24):Day 1	2360 (648)	4815 (910)	8146 (1275)	7406 (1368)	14403 (1557)	12499 (3457)	1201 (454)	8038 (1898)	4806 (509)	7932 (1190)
AUC from time zero to 24 hour (AUC 0-24): Day 5, only part 2	–	–	–	–	–	–	–	–	4698 (499)	8059 (1278)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 days in part 1, 12 days in part 2. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A Single Dose MT-1186 (Part 1, Cohort S1)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
A Single Dose MT-1186 (Part 1, Cohort S2)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
A Single Dose MT-1186 (Part 1, Cohort S3)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
A Single Dose MT-1186 (Part 1, Cohort S4)	0 of 6 (0%)	0 of 6 (0%)	0 of 6
A Single Dose MT-1186 (Part 1, Cohort S5)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
A Single Dose MT-1186 (Part 1, Cohort S6)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
A Single Dose MT-1186 (Part 1, Cohort S7)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Matching Placebo (a Single Dose Cohorts)	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14
Multiple Doses MT-1186 (Part 2, Cohort M1)	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Multiple Doses MT-1186 (Part 2, Cohort M2)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Matching Placebo (Multiple Doses Cohorts)	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33704925Shimizu 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.
Derived from this study: PubMed 36376130Shimizu 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shionogi Clinical Trials Administrator Clinical Support Help Line study director

Shionogi

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MT-1186 in people with Healthy Adult Subjects, run by Shionogi at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (Aes) and Adverse Drug Reactions (ADRs) (time frame: Day 1 to 8 in Part 1, up to 12 days in Part 2). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04481750, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.