Healthy Adult SubjectsPhase 1NCT05342597

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

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 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. Read more about this study

Who is it for?: Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Adult Subjects
What is being tested?: MT-1186
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteJapan
Study dates: 10 Jun 2019to 24 Jul 2019
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

Subjects who met any of the following exclusion criteria between screening and investigational product administration were excluded from the study:
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

Show all 20Show fewer

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
Use of grapefruit, grapefruit juice, or any processed food(s) containing these substances within 24 hours before screening and visit on Day -1
Use of any tobacco or nicotine-containing product(s) within 24 hours before screening and visit on Day -1
Female subjects who have a positive pregnancy test at screening and on Day -1, are pregnant or breast feeding, or plan to get pregnant during the study
Subjects judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason

Trial locations and contacts

1 site in 1 country.

Japan1 site

Investigational site
Tokyo

Other trials in Japan

About this study

Conditions: Healthy Adult Subjects
Being tested: MT-1186

What participants receive

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

MT-1186Drug
Also called Edaravone
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.

Study groups in NCT05342597
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: MT-1186

What is being measured

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

Area Under the Concentration Versus Time Curve From Zero up to Infinity (AUC0-inf) of Edaravone
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 to 9, Day 24 to 26
Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate
Measured: Day 1 to 9, Day 24 to 26
Renal Clearance (CLr) of Unchanged Edaravone
Measured: Day 1 to 9, Day 24 to 26

Secondary outcomes (1)

Number of Participants With Adverse Events and Adverse Drug Reactions
Measured: Day 1 to Day 31

Timeline

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

10 Jun 201924 Jul 2019

First posted22 Apr 2022
Study start10 Jun 2019
Primary completion24 Jul 2019
Study completion24 Jul 2019

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 (1)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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05342597
Sponsor's protocol ID: MT-1186-J06
Status last verified: Jun 2026
First submitted: 19 Apr 2022
Last updated: 15 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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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Healthy Subjects

All Healthy Adult Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study)
ClinicalTrials.gov ID: NCT05342597
Acronym / sponsor ID: MT-1186-J06
Conditions: Healthy Adult Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Study start: 10 Jun 2019 (actual)
Primary completion: 24 Jul 2019 (actual)
Study completion: 24 Jul 2019 (actual)
First posted: 22 Apr 2022 (actual)
Results: Posted 5 Jan 2024

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group A	Experimental	Drug: MT-1186A 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.
Group B	Experimental	Drug: MT-1186A 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.
Group C	Experimental	Drug: MT-1186A 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.
Group D	Experimental	Drug: MT-1186A 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.

Who may qualify

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

Key inclusion criteria (5 listed)

Subjects who meet all of the following criteria and who have the capability of giving informed consent will be included in the study.

Key exclusion criteria (20 listed)

Subjects who met any of the following exclusion criteria between screening and investigational product administration were excluded from the study:

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: EdaravoneA 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.	Drug	Group A, Group B, Group C, Group D

Primary outcome

Area Under the Concentration Versus Time Curve From Zero up to Infinity (AUC0-inf) of Edaravone
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 to 9, Day 24 to 26
Urinary Excretion Ratio (Ae% 0-24h) of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate
Time frame: Day 1 to 9, Day 24 to 26
Renal Clearance (CLr) of Unchanged Edaravone
Time frame: Day 1 to 9, Day 24 to 26

1 secondary outcome

Number of Participants With Adverse Events and Adverse Drug Reactions
Time frame: Day 1 to Day 31

Results and safety

Results posted to the registry on 5 Jan 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
Group A	4	4
Group B	4	4
Group C	4	4
Group D	4	4

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

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

Measure	Edaravone Single Dose Under Fasting Condition n = 16	Edaravone Single Dose 8 Hours After a High-fat Meal n = 16	Edaravone Single Dose 4 Hours After a Low-fat Meal n = 16	Edaravone Single Dose 2 Hours After a Light Meal n = 16	Edaravone Single Dose 2 Hours After a Low-fat Meal n = 16
Value	2165 (673)	2209 (658)	2073 (641)	1955 (523)	1717 (463)

Edaravone Single Dose Under Fasting Condition vs Edaravone Single Dose 8 Hours After a High-fat Meal: LS Mean Ratio: 1.025 (90% CI 0.931 to 1.128), ANOVA
Edaravone Single Dose Under Fasting Condition vs Edaravone Single Dose 4 Hours After a Low-fat Meal: LS Mean Ratio: 0.959 (90% CI 0.871 to 1.056), ANOVA
Edaravone Single Dose Under Fasting Condition vs Edaravone Single Dose 2 Hours After a Light Meal: LS Mean Ratio: 0.910 (90% CI 0.827 to 1.002), ANOVA

Population analysed: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Primary outcome: Maximum Plasma Concentration (Cmax) of Edaravone

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

Measure	Edaravone Single Dose Under Fasting Condition n = 16	Edaravone Single Dose 8 Hours After a High-fat Meal n = 16	Edaravone Single Dose 4 Hours After a Low-fat Meal n = 16	Edaravone Single Dose 2 Hours After a Light Meal n = 16	Edaravone Single Dose 2 Hours After a Low-fat Meal n = 16
Value	2318 (1229)	2525 (1337)	2020 (1114)	1898 (865.9)	1276 (805.6)

Edaravone Single Dose Under Fasting Condition vs Edaravone Single Dose 8 Hours After a High-fat Meal: LS Mean Ratio: 1.083 (90% CI 0.821 to 1.429), ANOVA
Edaravone Single Dose Under Fasting Condition vs Edaravone Single Dose 4 Hours After a Low-fat Meal: LS Mean Ratio: 0.872 (90% CI 0.661 to 1.150), ANOVA
Edaravone Single Dose Under Fasting Condition vs Edaravone Single Dose 2 Hours After a Light Meal: LS Mean Ratio: 0.820 (90% CI 0.621 to 1.082), ANOVA

Population analysed: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Primary outcome: AUC0-inf of Sulfate Conjugate and Glucuronide Conjugate

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

Measure	Edaravone Single Dose Under Fasting Condition n = 16	Edaravone Single Dose 8 Hours After a High-fat Meal n = 16	Edaravone Single Dose 4 Hours After a Low-fat Meal n = 16	Edaravone Single Dose 2 Hours After a Light Meal n = 16	Edaravone Single Dose 2 Hours After a Low-fat Meal n = 16
Sulfate conjugate	24519 (7243)	25724 (7729)	24671 (6077)	25903 (8657)	26293 (10355)
Glucuronide conjugate	4054 (791)	3895 (796)	4109 (891)	3914 (841)	4325 (1054)

Population analysed: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

Primary outcome: Cmax of Sulfate Conjugate and Glucuronide Conjugate

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

Measure	Edaravone Single Dose Under Fasting Condition n = 16	Edaravone Single Dose 8 Hours After a High-fat Meal n = 16	Edaravone Single Dose 4 Hours After a Low-fat Meal n = 16	Edaravone Single Dose 2 Hours After a Light Meal n = 16	Edaravone Single Dose 2 Hours After a Low-fat Meal n = 16
Sulfate conjugate	8456 (2041)	9024 (2430)	8629 (1960)	8665 (2362)	7986 (2288)
Glucuronide conjugate	2283 (496.2)	2209 (645.9)	2283 (486.7)	2141 (548.1)	2031 (608.9)

Population analysed: Four groups of randomized participants received edaravone oral suspension under 5 dosing conditions (4 subjects per group, 16 subjects per dosing condition).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day 1 to Day 31. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Edaravone Single Dose Under Fasting Condition	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Edaravone Single Dose 8 Hours After a High-fat Meal	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Edaravone Single Dose 4 Hours After a Low-fat Meal	0 of 16 (0%)	1 of 16 (6.3%)	0 of 16
Edaravone Single Dose 2 Hours After a Light Meal	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Edaravone Single Dose 2 Hours After a Low-fat Meal	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: 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 20 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 15 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 5 Jan 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?

Area Under the Concentration Versus Time Curve From Zero up to Infinity (AUC0-inf) of Edaravone (time frame: 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). The study lists 14 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 NCT05342597, which also lists 1 linked publication.

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 15 Jul 2026.