CompletedNCT03289234Updated Jul 15, 2026Results posted

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

A Phase 1 interventional study of MCI-186 in Hepatic Impairment and Healthy, sponsored by Shionogi. Completed at 2 sites in Japan. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by Shionogi · Phase 1, Interventional, and Other

Phase: Phase 1
Study type: Interventional
Enrollment: 22
Allocation: Non-randomized
Ages: 20 Years to 75 Years
Sex: All

Study 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

Conditions studied

Hepatic Impairment
Healthy

Who can participate

Ages eligible: 20 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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)

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 22 participants (actual)

Study arms

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

Interventions

DrugMCI-186
30 mg of edaravone will be administered intravenously over 60 minutes
Also known as: Edaravone, Radicut

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Posted Feb 28, 2020

Participant flow

Participant flow — Overall Study
Milestone	Mild Hepatic Impairment	Moderate Hepatic Impairment	Normal Hepatic Function
Started	8	6	8
Completed	8	6	8
Not completed	0	0	0

Outcome measures

PrimaryCmax

Time frame:: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
Reported as:: Mean · ng/mL

Cmax
ng/mL	Mild Hepatic Impairment	Moderate Hepatic Impairment	Normal Hepatic Function
Cmax	538.1 ± 182.3	533.4 ± 88.57	429 ± 44.36

PrimaryAUC0-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
Reported as:: Mean · ng*hr/mL

AUC0-last
ng*hr/mL	Mild Hepatic Impairment	Moderate Hepatic Impairment	Normal Hepatic Function
AUC0-last	716.86 ± 258.3	739.28 ± 146.89	582.89 ± 58.33

PrimaryAUC0-∞

Time frame:: pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
Reported as:: Mean · ng*hr/mL

AUC0-∞
ng*hr/mL	Mild Hepatic Impairment	Moderate Hepatic Impairment	Normal Hepatic Function
AUC0-∞	727.55 ± 262.04	751.52 ± 148.34	594.96 ± 63.58

Secondaryt½

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

t½
hour	Mild Hepatic Impairment	Moderate Hepatic Impairment	Normal Hepatic Function
t½	3.14 ± 0.58	4.37 ± 1.9	5.41 ± 6.58

Adverse events

Collected over 7 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Mild Hepatic Impairment	0/8 (0%)	0/8 (0%)	0/8 (0%)
Moderate Hepatic Impairment	0/6 (0%)	0/6 (0%)	1/6 (16.7%)
Normal Hepatic Function	0/8 (0%)	0/8 (0%)	0/8 (0%)

Most frequent other events

Most frequent other events
Event	Mild Hepatic Impairment	Moderate Hepatic Impairment	Normal Hepatic Function
Chest painGeneral disorders	0/8	1/6	0/8

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Mild Hepatic Impairment	Moderate Hepatic Impairment	Normal Hepatic Function	Total
Mean	59.6 ± 11.9	66.2 ± 5.3	61.6 ± 2.7	62.1 ± 8

Sex: Female, Male
Sex: Female, Male(Participants)	Mild Hepatic Impairment	Moderate Hepatic Impairment	Normal Hepatic Function	Total
Female	2	1	2	5
Male	6	5	6	17

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Mild Hepatic Impairment	Moderate Hepatic Impairment	Normal Hepatic Function	Total
American Indian or Alaska Native	0	0	0	0
Asian	8	6	8	22
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	0	0
White	0	0	0	0
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Study locations

2 sites

Investigational site
Fukuoka, Japan
Investigational site
Tokyo, Japan

References and documents

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 ↗

Study documents

Study protocol · Apr 2, 2018
Statistical analysis plan · Oct 9, 2018

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT03289234
Lead sponsor: Shionogi
Responsible party: Sponsor
First posted: Sep 20, 2017
Start date: Nov 16, 2016
Primary completion: Jul 20, 2018
Completion: Jul 24, 2018
Results posted: Feb 28, 2020
Last update: Jul 15, 2026

Study contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line

study director · Shionogi

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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