Healthy Adult SubjectsPhase 1NCT04029090

A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy Subjects

A Phase 1 study testing MCI-186 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 MCI-186 on the QT interval corrected for heart rate using Fridericia's formula (QTcF) Read more about this study

Who is it for?: Ages 20 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Adult Subjects
What is being tested?: MCI-186
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteJapan
Study dates: 18 Sep 2018to 23 Oct 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 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males aged 20 to 55 years (both inclusive) at signature of the Informed Consent Form (ICF).
Able to provide written informed consent to participate in this study after reading the ICF, and after having the opportunity to discuss the study with the Investigator or designee, before any screening or study related procedures take place.
In the Investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements.
A body weight of ≥45 kg and a body mass index (BMI) ranging from 18 to 30 kg/m2 (both inclusive) at screening and Day -1.
Good health and free from clinically significant illness or disease in the opinion of the investigator on the basis of a physical examination, medical history, ECG, vital sign, and clinical laboratory test (biochemistry, hematology, coagulation and urinalysis) at screening and Day -1.
Male subjects must practice effective contraception during the study, from the time of the first dose of Investigational Medicinal Product (IMP) until 14 days after the last dose of IMP.

Who cannot join

Subjects with PR >240 msec, QRS ≥120 msec, or QTcF >450 msec on the screening or Day -1 ECG, or any clinically significant electrocardiographic abnormality in the opinion of the Investigator.
Subject who has a history of cardiac disease or arrhythmias that can cause QTc prolongation.
Subject who has a family history of Torsade de Pointes, long-QT syndrome, hypokalemia or sudden death.
Subjects with potassium levels outside of the laboratory reference ranges at screening or Day -1.
Subjects with clinically significant deviations from normal in physical examination, vital signs, ECG or clinical laboratory test at screening or Day -1 in the opinion of the Investigator.
Presence or history of any clinically significant disease or organ dysfunction in the opinion of the Investigator.

Show all 17Show fewer

Presence or history of allergy to food, any medical product or relevant excipient that is of clinical significant.
Subjects were previously administered MCI-186.
Presence or history of alcohol abuse or a positive alcohol test.
Presence or history of drug abuse or a positive drug screen test.
Positive test for hepatitis C virus antibody, hepatitis B surface antigen, human immunodeficiency virus (HIV) antigen/antibody or syphilis test at screening.
Participation in another trial within 12 weeks or 5 times the half-life of the drug whichever is longer before providing a signed ICF. For biologics, the minimum period is at least 24 weeks or the period of the pharmacodynamic effect, or 10 times the half-life of the drug, whichever is longer before providing a signed ICF.
Donate blood more than 200 mL within 4 weeks, 400 mL within 12 weeks or 1000 mL within 52 weeks, respectively before providing a signed ICF.
Donate plasma or platelet component within 2 weeks before providing a signed ICF.
Use of any prescription or non-prescription medications including herbal remedies and vitamin/mineral/protein supplements, except for acetylsalicylic acid, within 7 days prior to IMPs dosing.
Use of tobacco or nicotine containing products for 24 hours before each visit of screening or Day -1.
Consumption of alcohol, xanthines, or grapefruit containing products for 24 hours before each visit of screening or Day -1.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Investigational site
Tokyo

Other trials in Japan

About this study

Official title: A Randomized, Single-Blind, Placebo-Controlled, Three-Way Crossover Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT/QTc Interval in Healthy Subjects

To evaluate the effect of MCI-186 on the QT interval corrected for heart rate using Fridericia's formula (QTcF)

Conditions: Healthy Adult Subjects
Being tested: MCI-186, Placebo

What participants receive

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

MCI-186Drug
Also called Edaravone
A single dose of 60 mg MCI-186 over 60 min will be intravenously administered.
MCI-186Drug
Also called Edaravone
A single dose of 300 mg MCI-186 over 60 min will be intravenously administered.
PlaceboDrug
A single dose of 0.9% w/v saline over 60 min will be intravenously administered.

Study groups in NCT04029090
Study group	Role	What they receive
Sequence 1	Experimental	Subjects will receive a single intravenous dose of MCI-186 as a 1-hour infusion in the treatment sequence: first Treatment A, then Treatment C, then Treatment B (Treatment A= 60 mg of MCI-186, Treatment B= 300 mg of MCI-186, treatment C=0.9% w/v saline) Receives: Drug: MCI-186; Drug: Placebo
Sequence 2	Experimental	Subjects will receive a single intravenous dose of MCI-186 as a 1-hour infusion in the treatment sequence: first Treatment B, then Treatment A, then Treatment C (Treatment A= 60 mg of MCI-186, Treatment B= 300 mg of MCI-186, treatment C=0.9% w/v saline) Receives: Drug: MCI-186; Drug: Placebo
Sequence 3	Experimental	Subjects will receive a single intravenous dose of MCI-186 as a 1-hour infusion in the treatment sequence: first Treatment C, then Treatment B, then Treatment A (Treatment A= 60 mg of MCI-186, Treatment B= 300 mg of MCI-186, treatment C=0.9% w/v saline) Receives: Drug: MCI-186; Drug: Placebo

What is being measured

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

Change From Baseline in QTcF(ΔQTcF) With Placebo Adjustment (ΔΔQTcF) at Cmax of MCI-186
The primary outcome endpoint was based on an analysis of the regression relationship between ΔQTcF and the concentration of MCI-186 at matching times post-dose, including adjustment for placebo treatments.
Measured: 45 min pre-dose to 24 h post-dose

Secondary outcomes (8)

Change From Baseline of Heart Rate(HR) by Timepoint
Measured: Pre-dose to 24h post-dose
Change From Baseline of PR Interval by Timepoint
Measured: Pre-dose to 24h post-dose
Change From Baseline of QRS Interval by Timepoint
Measured: Pre-dose to 24h post-dose
Change From Baseline of QTcF by Timepoint
Measured: Pre-dose to 24h post-dose
Plasma Concentration of MCI-186
Measured: Pre-dose to 24h post-dose
Pharmacokinetic(PK) Parameters - Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC 0-inf) of MCI-186
Measured: Pre-dose to 24h post-dose
PK Parameters - Maximum Plasma Concentration (Cmax) of MCI-186
Measured: Pre-dose to 24h post-dose
Number of Participants With Adverse Events (AEs)
Measured: Day 1 to 9

Timeline

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

18 Sep 201823 Oct 2018

First posted23 Jul 2019
Study start18 Sep 2018
Primary completion20 Oct 2018
Study completion23 Oct 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 (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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04029090
Sponsor's protocol ID: MCI-186-J25
Status last verified: Jun 2026
First submitted: 10 Jul 2019
Last updated: 15 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Shimizu H, Inoue S, Endo M, Nakamaru Y, Yoshida K, Natori T, Kakubari M, Akimoto M, Kondo K. A Randomized, Single-Blind, Placebo-Controlled, 3-Way Crossover Study to Evaluate the Effect of Therapeutic and Supratherapeutic Doses of Edaravone on QT/QTc Interval in Healthy Subjects. Clin Pharmacol Drug Dev. 2021 Jan;10(1):46-56. doi: 10.1002/cpdd.814. Epub 2020 Jun 15.
PubMed 32543120

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?

See locations

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Healthy Subjects

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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: A Randomized, Single-Blind, Placebo-Controlled, Three-Way Crossover Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT/QTc Interval in Healthy Subjects
ClinicalTrials.gov ID: NCT04029090
Acronym / sponsor ID: MCI-186-J25
Conditions: Healthy Adult Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Study start: 18 Sep 2018 (actual)
Primary completion: 20 Oct 2018 (actual)
Study completion: 23 Oct 2018 (actual)
First posted: 23 Jul 2019 (actual)
Results: Posted 21 Nov 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 effect of MCI-186 on the QT interval corrected for heart rate using Fridericia's formula (QTcF)

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Sequence 1	Experimental	Drug: MCI-186, Drug: PlaceboSubjects will receive a single intravenous dose of MCI-186 as a 1-hour infusion in the treatment sequence: first Treatment A, then Treatment C, then Treatment B (Treatment A= 60 mg of MCI-186, Treatment B= 300 mg of MCI-186, treatment C=0.9% w/v saline)
Sequence 2	Experimental	Drug: MCI-186, Drug: PlaceboSubjects will receive a single intravenous dose of MCI-186 as a 1-hour infusion in the treatment sequence: first Treatment B, then Treatment A, then Treatment C (Treatment A= 60 mg of MCI-186, Treatment B= 300 mg of MCI-186, treatment C=0.9% w/v saline)
Sequence 3	Experimental	Drug: MCI-186, Drug: PlaceboSubjects will receive a single intravenous dose of MCI-186 as a 1-hour infusion in the treatment sequence: first Treatment C, then Treatment B, then Treatment A (Treatment A= 60 mg of MCI-186, Treatment B= 300 mg of MCI-186, treatment C=0.9% w/v saline)

Who may qualify

Ages: 20 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Healthy males aged 20 to 55 years (both inclusive) at signature of the Informed Consent Form (ICF).
Able to provide written informed consent to participate in this study after reading the ICF, and after having the opportunity to discuss the study with the Investigator or designee, before any screening or study related procedures take place.
In the Investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements.
A body weight of ≥45 kg and a body mass index (BMI) ranging from 18 to 30 kg/m2 (both inclusive) at screening and Day -1.
Good health and free from clinically significant illness or disease in the opinion of the investigator on the basis of a physical examination, medical history, ECG, vital sign, and clinical laboratory test (biochemistry, hematology, coagulation and urinalysis) at screening and Day -1.

Key exclusion criteria (17 listed)

Subjects with PR >240 msec, QRS ≥120 msec, or QTcF >450 msec on the screening or Day -1 ECG, or any clinically significant electrocardiographic abnormality in the opinion of the Investigator.
Subject who has a history of cardiac disease or arrhythmias that can cause QTc prolongation.
Subject who has a family history of Torsade de Pointes, long-QT syndrome, hypokalemia or sudden death.
Subjects with potassium levels outside of the laboratory reference ranges at screening or Day -1.
Subjects with clinically significant deviations from normal in physical examination, vital signs, ECG or clinical laboratory test at screening or Day -1 in the opinion of the Investigator.

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
MCI-186Also: EdaravoneA single dose of 60 mg MCI-186 over 60 min will be intravenously administered.	Drug	Sequence 1, Sequence 2, Sequence 3
MCI-186Also: EdaravoneA single dose of 300 mg MCI-186 over 60 min will be intravenously administered.	Drug	Sequence 1, Sequence 2, Sequence 3
PlaceboA single dose of 0.9% w/v saline over 60 min will be intravenously administered.	Drug	Sequence 1, Sequence 2, Sequence 3

Primary outcome

Change From Baseline in QTcF(ΔQTcF) With Placebo Adjustment (ΔΔQTcF) at Cmax of MCI-186
Time frame: 45 min pre-dose to 24 h post-dose
The primary outcome endpoint was based on an analysis of the regression relationship between ΔQTcF and the concentration of MCI-186 at matching times post-dose, including adjustment for placebo treatments.

8 secondary outcomes

Change From Baseline of Heart Rate(HR) by Timepoint
Time frame: Pre-dose to 24h post-dose
Change From Baseline of PR Interval by Timepoint
Time frame: Pre-dose to 24h post-dose
Change From Baseline of QRS Interval by Timepoint
Time frame: Pre-dose to 24h post-dose
Change From Baseline of QTcF by Timepoint
Time frame: Pre-dose to 24h post-dose
Plasma Concentration of MCI-186
Time frame: Pre-dose to 24h post-dose
Pharmacokinetic(PK) Parameters - Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC 0-inf) of MCI-186
Time frame: Pre-dose to 24h post-dose
PK Parameters - Maximum Plasma Concentration (Cmax) of MCI-186
Time frame: Pre-dose to 24h post-dose
Number of Participants With Adverse Events (AEs)
Time frame: Day 1 to 9

Results and safety

Results posted to the registry on 21 Nov 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
Sequence 1 (Treatment A, Then Treatment C, Then Treatment B)	9	8
Sequence 2 (Treatment B, Then Treatment A, Then Treatment C)	9	8
Sequence 3 (Treatment C, Then Treatment B, Then Treatment A)	9	9

Primary outcome: Change From Baseline in QTcF(ΔQTcF) With Placebo Adjustment (ΔΔQTcF) at Cmax of MCI-186

Time frame: 45 min pre-dose to 24 h post-dose. Mean (90% Confidence Interval). Unit: ms

Measure	MCI-186 60mg n = 27	MCI-186 300mg n = 26
Value	-0.5 (-1.5 to 0.5)	0.5 (-1.0 to 1.9)

Population analysed: All participants who received 600mg, and 300mg of MCI-186 were included in the analysis. One participant on 300mg was not included due to meeting the exclusion criteria (Protocol Violation). Overall Number of Participants Analyzed was entered as the number at the time of calculation of Cmax.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 9 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MCI-186 60mg	0 of 27 (0%)	1 of 27 (3.7%)	0 of 27
MCI-186 300mg	0 of 26 (0%)	1 of 26 (3.8%)	0 of 26
Placebo	0 of 25 (0%)	1 of 25 (4%)	0 of 25

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 32543120Shimizu H, Inoue S, Endo M, Nakamaru Y, Yoshida K, Natori T, Kakubari M, Akimoto M, Kondo K. A Randomized, Single-Blind, Placebo-Controlled, 3-Way Crossover Study to Evaluate the Effect of Therapeutic and Supratherapeutic Doses of Edaravone on QT/QTc Interval in Healthy Subjects. Clin Pharmacol Drug Dev. 2021 Jan;10(1):46-56. doi: 10.1002/cpdd.814. Epub 2020 Jun 15.

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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 MCI-186 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 6 inclusion and 17 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 21 Nov 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?

Change From Baseline in QTcF(ΔQTcF) With Placebo Adjustment (ΔΔQTcF) at Cmax of MCI-186 (time frame: 45 min pre-dose to 24 h post-dose). 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 NCT04029090, 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.