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Liver function may change how MCI-186 acts in the body

NCT ID NCT03289234

Knowledge-focused Sponsor: Shionogi Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This study looked at how the drug MCI-186 (also called edaravone) behaves in people with mild or moderate liver impairment compared to those with healthy livers. Twenty-two participants received a single dose of the drug. The goal was to see if liver problems affect how the drug is processed, which could help guide future dosing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MCI-186 (edaravone)
What this could lead to
If successful, this study could help determine safe dosing of edaravone for patients with liver impairment.
What could go wrong
This is a small, early-phase study focused on drug processing, not treatment effects. Results may not apply to broader populations or predict real-world outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

22 people

The number who actually took part.

Started

Nov 2016

Finished

Jul 2018

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

liver disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy Hepatic impairment

Contacts and locations

Locations

  • Investigational site

    Fukuoka, Japan

  • Investigational site

    Tokyo, Japan

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Other studies related to the condition(s) this trial covers.