Hepatic ImpairmentPhase 1NCT03289234

Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment

A Phase 1 study testing MCI-186 in people with Hepatic Impairment and Healthy, run by Shionogi at 2 sites in Japan.

Completed

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

Trial summary

To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic function Read more about this study

Who is it for?: Ages 20 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Impairment, Healthy
What is being tested?: MCI-186
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 2 sitesJapan
Study dates: 16 Nov 2016to 24 Jul 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 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All subjects
Able to provide written informed consent to participate in this study after reading the ICF
Subjects is able to understand and willing to cooperate and comply with the Protocol restrictions and requirements.
A body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging from 18 to 30 kg/m2
Hepatic impaired subjects (in addition)
A Child-Pugh score of 5 or 6 for subjects with mild hepatic impairment, and between 7 and 9, inclusive, for subjects with moderate hepatic impairment

Show all 10Show fewer

Chronic and stable hepatic impairment
Healthy subjects (in addition)
Subject with normal hepatic function
Good health and free from clinically significant illness or disease

Who cannot join

All subjects
Presence or history of severe allergy to food, or any medicinal product or relevant excipient that is of clinical significance
Subjects were previously administered MCI-186.
Positive urine drug screen (if not due to concomitant medication) or alcohol test
History of drug abuse
Presence of alcohol abuse

Show all 15Show fewer

Presence of active infection requiring antibiotics
Positive test for human immunodeficiency virus (HIV) antigen/antibody
Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>160 mmHg and/or diastolic blood pressure (DBP)>100 mmHg
eGFR <60 mL/min/1.73m2
Hepatic impairment subject (in addition)
Subjects with severe ascites
Healthy subject (in addition)
History or presence of any parenchymal hepatic disease
Positive test for hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCVAb)

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

Investigational site
Fukuoka
Investigational site
Tokyo

Other trials in Japan

About this study

Official title: A Multi-Center, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function

To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic function

Conditions: Hepatic Impairment, Healthy
Being tested: MCI-186

What participants receive

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

MCI-186Drug
Also called Edaravone, Radicut
30 mg of edaravone will be administered intravenously over 60 minutes

Study groups in NCT03289234
Study group	Role	What they receive
mild hepatic impairment	Experimental	Not described Receives: Drug: MCI-186
moderate hepatic impairment	Experimental	Not described Receives: Drug: MCI-186
normal hepatic function	Experimental	Not described Receives: Drug: MCI-186

What is being measured

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

Cmax
Measured: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
AUC0-last
Measured: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
AUC0-∞
Measured: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose

Secondary outcomes (1)

t½
Measured: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose

Timeline

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

16 Nov 201624 Jul 2018

First posted20 Sep 2017
Study start16 Nov 2016
Primary completion20 Jul 2018
Study completion24 Jul 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 Hepatic ImpairmentStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03289234
Sponsor's protocol ID: MCI-186-J23
Status last verified: Jun 2026
First submitted: 19 Sep 2017
Last updated: 15 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Nakamaru Y, Kakubari M, Yoshida K, Akimoto M, Todorovic V, Greis T, Kondo K. Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning. Clin Ther. 2020 Aug;42(8):1467-1482.e4. doi: 10.1016/j.clinthera.2020.06.016. Epub 2020 Aug 14.
PubMed 32800532

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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All Hepatic Impairment 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: A Multi-Center, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
ClinicalTrials.gov ID: NCT03289234
Acronym / sponsor ID: MCI-186-J23
Conditions: Hepatic Impairment, Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Study start: 16 Nov 2016 (actual)
Primary completion: 20 Jul 2018 (actual)
Study completion: 24 Jul 2018 (actual)
First posted: 20 Sep 2017 (actual)
Results: Posted 28 Feb 2020

Clinical summary

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

To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic function

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
mild hepatic impairment	Experimental	Drug: MCI-186
moderate hepatic impairment	Experimental	Drug: MCI-186
normal hepatic function	Experimental	Drug: MCI-186

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

All subjects
Able to provide written informed consent to participate in this study after reading the ICF
Subjects is able to understand and willing to cooperate and comply with the Protocol restrictions and requirements.
A body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging from 18 to 30 kg/m2
Hepatic impaired subjects (in addition)

Key exclusion criteria (15 listed)

All subjects
Presence or history of severe allergy to food, or any medicinal product or relevant excipient that is of clinical significance
Subjects were previously administered MCI-186.
Positive urine drug screen (if not due to concomitant medication) or alcohol test
History of drug abuse

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: Edaravone, Radicut30 mg of edaravone will be administered intravenously over 60 minutes	Drug	mild hepatic impairment, moderate hepatic impairment, normal hepatic function

Primary outcome

Cmax
Time frame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
AUC0-last
Time frame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
AUC0-∞
Time frame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose

1 secondary outcome

t½
Time frame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose

Results and safety

Results posted to the registry on 28 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mild Hepatic Impairment	8	8
Moderate Hepatic Impairment	6	6
Normal Hepatic Function	8	8

Primary outcome: Cmax

Time frame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Mild Hepatic Impairment n = 8	Moderate Hepatic Impairment n = 6	Normal Hepatic Function n = 8
Value	538.1 (182.3)	533.4 (88.57)	429 (44.36)

Population analysed: PK population

Primary outcome: AUC0-last

Time frame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Mild Hepatic Impairment n = 8	Moderate Hepatic Impairment n = 6	Normal Hepatic Function n = 8
Value	716.86 (258.3)	739.28 (146.89)	582.89 (58.33)

Population analysed: PK population

Primary outcome: AUC0-∞

Time frame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose. Mean (Standard Deviation). Unit: ng*hr/mL

Measure	Mild Hepatic Impairment n = 8	Moderate Hepatic Impairment n = 6	Normal Hepatic Function n = 8
Value	727.55 (262.04)	751.52 (148.34)	594.96 (63.58)

Population analysed: PK population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mild Hepatic Impairment	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Moderate Hepatic Impairment	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Normal Hepatic Function	0 of 8 (0%)	0 of 8 (0%)	0 of 8

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.
Derived from this study: PubMed 32800532Nakamaru Y, Kakubari M, Yoshida K, Akimoto M, Todorovic V, Greis T, Kondo K. Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning. Clin Ther. 2020 Aug;42(8):1467-1482.e4. doi: 10.1016/j.clinthera.2020.06.016. Epub 2020 Aug 14.

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RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
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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

2 sites 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 Hepatic Impairment and Healthy, run by Shionogi at 2 sites 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 10 inclusion and 15 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 2 sites 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 28 Feb 2020). 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?

Cmax (time frame: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose). The study lists 3 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 NCT03289234, 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.