Healthy Adult SubjectsPhase 1NCT04481789

Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)

A Phase 1 study testing MT-1186, Rosuvastatin and Sildenafil 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.

Official record

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Trial summary

Cohort 1: To evaluate the drug interactions, safety, and tolerability of oral edaravone when coadministered with rosuvastatin, sildenafil or furosemide in healthy adult males Cohort 2: To evaluate the pharmacokinetics, safety, and tolerability of oral edaravone in healthy Japanese and Caucasian 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, Rosuvastatin and Sildenafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteJapan
Study dates: 17 Oct 2018to 8 Jan 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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male volunteers
Cohort 1: Japanese, Cohort 2: 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

Show all 13Show fewer

Subjects who have participated in another clinical study and received a study drug within 12 weeks before providing informed consent
Use of any drug(s) other than the study drug or as-needed use of acetylsalicylic acid within 7 days before the initiation of study drug or victim drug administration
Use of any alcohol, xanthine, or caffeine-containing product(s) within 24 hours before screening and Day -1 visiting
Use of any supplement(s) within 7 days before the initiation of study drug or victim drug administration
Use of grapefruit, grapefruit juice, or any processed food(s) containing these substances during the following periods (Cohort 1: within 7 days before the initiation of victim drug administration, Cohort 2: within 24 hours before each Day -1 visiting)
Use of any tobacco or nicotine-containing product(s) (Cohort 1: within 12 weeks before the initiation of victim drug administration during the following periods, Cohort 2: within 24 hours before each Day -1 visiting)
Use of any health food(s) containing St John's Wort (Hypericum perforatum) within 2 weeks before the initiation of victim drug administration (only in Cohort 1)

Trial locations and contacts

1 site in 1 country.

Japan1 site

Investigational site
Tokyo

Other trials in Japan

About this study

Cohort 1: To evaluate the drug interactions, safety, and tolerability of oral edaravone when coadministered with rosuvastatin, sildenafil or furosemide in healthy adult males
Cohort 2: To evaluate the pharmacokinetics, safety, and tolerability of oral edaravone in healthy Japanese and Caucasian adult males

Conditions: Healthy Adult Subjects
Being tested: MT-1186, Rosuvastatin, Sildenafil, Furosemide

What participants receive

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

MT-1186Drug
Also called Edaravone
Suspension
RosuvastatinDrug
Also called Crestor
Tablets
SildenafilDrug
Also called Viagra
Tablets
FurosemideDrug
Also called Lasix
Tablets

Study groups in NCT04481789
Study group	Role	What they receive
Rosuvastatin, Sildenafil, and MT-1186	Experimental	Group 1 of Cohort 1: A single-sequence study in which healthy male subjects receive a single dose of rosuvastatin on Day 1 followed by a single dose of sildenafil on Day 4. MT-1186 will be administered from Day 6 to 13 with co-administration of rosuvastatin and sildenafil on Day 9 and 12, respectively. Receives: Drug: MT-1186; Drug: Rosuvastatin; Drug: Sildenafil
Furosemide and MT-1186	Experimental	Group 2 of Cohort 1: A single-sequence study in which healthy male subjects receive a single dose of furosemide on Day 1. MT-1186 will be administered from Day 3 to 7 with co-administration of furosemide on Day 6. Receives: Drug: MT-1186; Drug: Furosemide
MT-1186	Experimental	Cohort 2: A three-way crossover study in which Japanese healthy male subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 4, and 7 according to their treatment sequence with 3-day wash out between doses. Caucasian healthy male subjects receive a single dose of MT-1186 at the same period with Japanese subjects under the corresponding condition on Day 1, 4, or 7 according to their treatment schedule. 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 Time Zero to Infinity (AUC0-inf) of Rosuvastatin, Sildenafil and Furosemide.
Measured: Before rosuvastatin dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before sildenafil dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before furosemide dosing and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose
Maximum Plasma Concentration (Cmax) of Rosuvastatin, Sildenafil and Furosemide.
Measured: Before rosuvastatin dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before sildenafil dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before furosemide dosing and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose
Tmax of Rosuvastatin, Sildenafil and Furosemide.
Measured: Before rosuvastatin dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before sildenafil dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before furosemide dosing and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose
T1/2 of Rosuvastatin, Sildenafil and Furosemide.
Measured: Before rosuvastatin dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before sildenafil dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before furosemide dosing and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose
AUC0-inf of Unchanged Edaravone.
Measured: Group 1 (Day 6, 9 and 12) and Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
Cmax of Unchanged Edaravone.
Measured: Group 1 (Day 6, 9 and 12) and Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
Tmax of Unchanged Edaravone.
Measured: Group 1 (Day 6, 9 and 12) and Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
T1/2 of Unchanged Edaravone.
Measured: Group 1 (Day 6, 9 and 12) and Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
AUC0-inf of Sulfate Conjugate.
Measured: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
Cmax of Sulfate Conjugate.
Measured: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
Tmax of Sulfate Conjugate.
Measured: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
T1/2 of Sulfate Conjugate.
Measured: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
AUC0-inf of Glucuronide Conjugate.
Measured: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
Cmax of Glucuronide Conjugate.
Measured: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
Tmax of Glucuronide Conjugate.
Measured: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
T1/2 of Glucuronide Conjugate.
Measured: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
AUC0-inf of Unchanged Edaravone.
Measured: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
Cmax of Unchanged Edaravone.
Measured: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
Tmax of Unchanged Edaravone.
Measured: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
T1/2 of Unchanged Edaravone.
Measured: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
AUCinf of Sulfate Conjugate and Glucuronide Conjugate.
Measured: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
Cmax of Sulfate Conjugate and Glucuronide Conjugate.
Measured: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
Tmax of Sulfate Conjugate and Glucuronide Conjugate.
Measured: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
T1/2 of Sulfate Conjugate and Glucuronide Conjugate.
Measured: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
T1/2 of Glucuronide Conjugate.
Measured: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
Number of Participants With Adverse Events and Adverse Drug Reactions
Measured: Day 1 to 20 in group 1 of cohort 1, Day 1 to 14 in group 2 of cohort 1, Day 1 to 14 of cohort 2

Secondary outcomes (4)

AUCinf of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate.
Measured: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
Cmax of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate.
Measured: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
Tmax of Unchanged Edaravone.
Measured: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
T1/2 of Unchanged Edaravone.
Measured: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 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.

17 Oct 20188 Jan 2019

First posted22 Jul 2020
Study start17 Oct 2018
Primary completion20 Dec 2018
Study completion8 Jan 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 (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: Non-randomised
Intervention model: Sequential
Model description: Cohort 1 is open-label, non-randomized, sequential, and add-on study. Cohort 2 is single-dose, open-label, randomized, and cross-over study.
Masking: None (open label)
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04481789
Sponsor's protocol ID: MT-1186-J02
Status last verified: Jun 2026
First submitted: 17 Jul 2020
Last updated: 15 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, 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
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

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 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 Males (Drug Interaction Study and Preliminary Regimen-Finding Study)
ClinicalTrials.gov ID: NCT04481789
Acronym / sponsor ID: MT-1186-J02
Conditions: Healthy Adult Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Study start: 17 Oct 2018 (actual)
Primary completion: 20 Dec 2018 (actual)
Study completion: 8 Jan 2019 (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.

Cohort 1: To evaluate the drug interactions, safety, and tolerability of oral edaravone when coadministered with rosuvastatin, sildenafil or furosemide in healthy adult males
Cohort 2: To evaluate the pharmacokinetics, safety, and tolerability of oral edaravone in healthy Japanese and Caucasian adult males

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
Model description: Cohort 1 is open-label, non-randomized, sequential, and add-on study. Cohort 2 is single-dose, open-label, randomized, and cross-over study.

Arm	Type	Receives
Rosuvastatin, Sildenafil, and MT-1186	Experimental	Drug: MT-1186, Drug: Rosuvastatin, Drug: SildenafilGroup 1 of Cohort 1: A single-sequence study in which healthy male subjects receive a single dose of rosuvastatin on Day 1 followed by a single dose of sildenafil on Day 4. MT-1186 will be administered from Day 6 to 13 with co-administration of rosuvastatin and sildenafil on Day 9 and 12, respectively.
Furosemide and MT-1186	Experimental	Drug: MT-1186, Drug: FurosemideGroup 2 of Cohort 1: A single-sequence study in which healthy male subjects receive a single dose of furosemide on Day 1. MT-1186 will be administered from Day 3 to 7 with co-administration of furosemide on Day 6.
MT-1186	Experimental	Drug: MT-1186Cohort 2: A three-way crossover study in which Japanese healthy male subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 4, and 7 according to their treatment sequence with 3-day wash out between doses. Caucasian healthy male subjects receive a single dose of MT-1186 at the same period with Japanese subjects under the corresponding condition on Day 1, 4, or 7 according to their treatment schedule.

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy adult male volunteers
Cohort 1: Japanese, Cohort 2: 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 (13 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: EdaravoneSuspension	Drug	Furosemide and MT-1186, MT-1186, Rosuvastatin, Sildenafil, and MT-1186
RosuvastatinAlso: CrestorTablets	Drug	Rosuvastatin, Sildenafil, and MT-1186
SildenafilAlso: ViagraTablets	Drug	Rosuvastatin, Sildenafil, and MT-1186
FurosemideAlso: LasixTablets	Drug	Furosemide and MT-1186

Primary outcome

Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Rosuvastatin, Sildenafil and Furosemide.
Time frame: Before rosuvastatin dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before sildenafil dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before furosemide dosing and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose
Maximum Plasma Concentration (Cmax) of Rosuvastatin, Sildenafil and Furosemide.
Time frame: Before rosuvastatin dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before sildenafil dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before furosemide dosing and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose
Tmax of Rosuvastatin, Sildenafil and Furosemide.
Time frame: Before rosuvastatin dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before sildenafil dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before furosemide dosing and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose
T1/2 of Rosuvastatin, Sildenafil and Furosemide.
Time frame: Before rosuvastatin dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before sildenafil dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before furosemide dosing and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose
AUC0-inf of Unchanged Edaravone.
Time frame: Group 1 (Day 6, 9 and 12) and Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
Cmax of Unchanged Edaravone.
Time frame: Group 1 (Day 6, 9 and 12) and Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
Tmax of Unchanged Edaravone.
Time frame: Group 1 (Day 6, 9 and 12) and Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
T1/2 of Unchanged Edaravone.
Time frame: Group 1 (Day 6, 9 and 12) and Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
AUC0-inf of Sulfate Conjugate.
Time frame: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
Cmax of Sulfate Conjugate.
Time frame: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
Tmax of Sulfate Conjugate.
Time frame: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
T1/2 of Sulfate Conjugate.
Time frame: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
AUC0-inf of Glucuronide Conjugate.
Time frame: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
Cmax of Glucuronide Conjugate.
Time frame: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
Tmax of Glucuronide Conjugate.
Time frame: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
T1/2 of Glucuronide Conjugate.
Time frame: Group 2 (Day 3 and 6): Pre-dose, 0.083, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 hours post-dose.
AUC0-inf of Unchanged Edaravone.
Time frame: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
Cmax of Unchanged Edaravone.
Time frame: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
Tmax of Unchanged Edaravone.
Time frame: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
T1/2 of Unchanged Edaravone.
Time frame: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
AUCinf of Sulfate Conjugate and Glucuronide Conjugate.
Time frame: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
Cmax of Sulfate Conjugate and Glucuronide Conjugate.
Time frame: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
Tmax of Sulfate Conjugate and Glucuronide Conjugate.
Time frame: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
T1/2 of Sulfate Conjugate and Glucuronide Conjugate.
Time frame: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
T1/2 of Glucuronide Conjugate.
Time frame: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
Number of Participants With Adverse Events and Adverse Drug Reactions
Time frame: Day 1 to 20 in group 1 of cohort 1, Day 1 to 14 in group 2 of cohort 1, Day 1 to 14 of cohort 2

4 secondary outcomes

AUCinf of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate.
Time frame: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
Cmax of Unchanged Edaravone, Sulfate Conjugate and Glucuronide Conjugate.
Time frame: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
Tmax of Unchanged Edaravone.
Time frame: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours post-dose
T1/2 of Unchanged Edaravone.
Time frame: Before dosing, and 0.083, 0.25, 0.5 1, 1.5, 2, 4, 6, 8, 10, 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
Rosuvastatin, Sildenafil, and Edaravone Group 1 of Cohort 1	32	31
Furosemide and Edaravone Group 2 of Cohort 1	34	34
Edaravone Group 3 of Cohort 2	3	3
Edaravone Group 4 of Cohort 2	3	3
Edaravone Group 5 of Cohort 2	3	3
Caucasian Group of Cohort 2	3	3

Primary outcome: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Rosuvastatin, Sildenafil and Furosemide.

Time frame: Before rosuvastatin dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before sildenafil dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before furosemide dosing and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Rosuvastatin Alone: Group 1 of Cohort 1 n = 32	Rosubastatin + Edaravone: Group 1 of Cohort 1 n = 31	Sildenafil Alone: Group 1 of Cohort 1 n = 31	Sildenafil + Edaravone: Group 1 of Cohort 1 n = 31	Furosemide Alone: Group 2 of Cohort 1 n = 34	Furosemide + Edaravone: Group 2 of Cohort 1 n = 34
Value	161 (66.8)	165 (60.2)	532 (236)	482 (195)	3861 (1031)	3906 (736.2)

Rosuvastatin Alone: Group 1 of Cohort 1 vs Rosubastatin + Edaravone: Group 1 of Cohort 1: LS Mean Ratio: 1.02 (90% CI 0.97 to 1.08)
Sildenafil Alone: Group 1 of Cohort 1 vs Sildenafil + Edaravone: Group 1 of Cohort 1: LS Mean Ratio: 0.93 (90% CI 0.88 to 0.99)
Furosemide Alone: Group 2 of Cohort 1 vs Furosemide + Edaravone: Group 2 of Cohort 1: LS Mean Ratio: 1.03 (90% CI 0.98 to 1.09)

Population analysed: This study was conducted in 2 cohorts; the first cohort assessed DDIs with multiple doses of oral edaravone, and the second cohort evaluated PK and racial differences in PK parameters with oral administration of edaravone. DDI effects of oral edaravone was evaluated based on the number of subjects in each period in Cohort 1 (Group 1: Period 1 to 3, Group 2: Period 1 and 2).

Primary outcome: Maximum Plasma Concentration (Cmax) of Rosuvastatin, Sildenafil and Furosemide.

Measure	Rosuvastatin Alone: Group 1 of Cohort 1 n = 32	Rosubastatin + Edaravone: Group 1 of Cohort 1 n = 31	Sildenafil Alone: Group 1 of Cohort 1 n = 31	Sildenafil + Edaravone: Group 1 of Cohort 1 n = 31	Furosemide Alone: Group 2 of Cohort 1 n = 34	Furosemide + Edaravone: Group 2 of Cohort 1 n = 34
Value	11.3 (5.0)	11.3 (5.0)	232 (135)	201 (97.9)	1676 (777.7)	1701 (506.5)

Rosuvastatin Alone: Group 1 of Cohort 1 vs Rosubastatin + Edaravone: Group 1 of Cohort 1: LS Mean Ratio: 0.98 (90% CI 0.91 to 1.06)
Sildenafil Alone: Group 1 of Cohort 1 vs Sildenafil + Edaravone: Group 1 of Cohort 1: LS Mean Ratio: 0.94 (90% CI 0.80 to 1.10)
Furosemide Alone: Group 2 of Cohort 1 vs Furosemide + Edaravone: Group 2 of Cohort 1: LS Mean Ratio: 1.08 (90% CI 0.96 to 1.23)

Primary outcome: Tmax of Rosuvastatin, Sildenafil and Furosemide.

Measure	Rosuvastatin Alone: Group 1 of Cohort 1 n = 32	Rosubastatin + Edaravone: Group 1 of Cohort 1 n = 31	Sildenafil Alone: Group 1 of Cohort 1 n = 31	Sildenafil + Edaravone: Group 1 of Cohort 1 n = 31	Furosemide Alone: Group 2 of Cohort 1 n = 34	Furosemide + Edaravone: Group 2 of Cohort 1 n = 34
Value	4.6 (1.5)	5.1 (1.4)	0.8 (0.4)	0.9 (0.5)	1.7 (1.1)	1.8 (1.1)

Primary outcome: T1/2 of Rosuvastatin, Sildenafil and Furosemide.

Measure	Rosuvastatin Alone: Group 1 of Cohort 1 n = 32	Rosubastatin + Edaravone: Group 1 of Cohort 1 n = 31	Sildenafil Alone: Group 1 of Cohort 1 n = 31	Sildenafil + Edaravone: Group 1 of Cohort 1 n = 31	Furosemide Alone: Group 2 of Cohort 1 n = 34	Furosemide + Edaravone: Group 2 of Cohort 1 n = 34
Value	14.4 (4.0)	12.1 (2.2)	2.8 (1.1)	3.5 (1.4)	6.9 (3.5)	5.8 (3.8)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Cohort 1 Group 1: Day 1 to Day 20. Cohort 1 Group 2 and Cohort 2: Day 1 to Day 14.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rosuvastatin Alone: Group 1 of Cohort 1	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Sildenafil Alone: Group 1 of Cohort 1	0 of 31 (0%)	2 of 31 (6.5%)	0 of 31
Edaravone Alone: Group 1 of Cohort 1	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Edaravone + Rosuvastatin: Group 1 of Cohort 1	0 of 31 (0%)	6 of 31 (19.4%)	0 of 31
Edaravone + Sildenafil: Group 1 of Cohort 1	0 of 31 (0%)	3 of 31 (9.7%)	0 of 31
Combined: After Day 6: Group 1 of Cohort 1	0 of 31 (0%)	8 of 31 (25.8%)	0 of 31
Furosemide Alone: Group 2 of Cohort 1	0 of 34 (0%)	1 of 34 (2.9%)	0 of 34
Edaravone Alone: Group 2 of Cohort 1	0 of 34 (0%)	0 of 34 (0%)	0 of 34
Edaravone + Furosemide: Group 2 of Cohort 1	0 of 34 (0%)	7 of 34 (20.6%)	0 of 34
Combined : After Day 3: Group 2 of Cohort 1	0 of 34 (0%)	7 of 34 (20.6%)	0 of 34
Edaravone Single Dose Under Fasting Condition: Japanese Conmibed	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Edaravone Single Dose 1 Hour After a High-fat Meal: Japanese Conmibed	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
Edaravone Single Dose 4 Hours After a High-fat Meal: Japanese Conmibed	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Edaravone Single Dose Under Fasting Condition: White Combined	0 of 9 (0%)	0 of 9 (0%)	0 of 9

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.
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.
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, Rosuvastatin and Sildenafil 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 4 inclusion and 13 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 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?

Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Rosuvastatin, Sildenafil and Furosemide. (time frame: Before rosuvastatin dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before sildenafil dosing and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose, Before furosemide dosing and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hrs post-dose). The study lists 26 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 NCT04481789, 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 15 Jul 2026.