NCT03289234

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2018

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2018

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 28, 2020

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

September 19, 2017

Results QC Date

February 13, 2020

Last Update Submit

December 15, 2025

Conditions

Hepatic ImpairmentHealthy

Outcome Measures

Primary Outcomes (3)

  • Cmax

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

  • AUC0-last

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

  • AUC0-∞

    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

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

Study Arms (3)

mild hepatic impairment

EXPERIMENTAL
Drug: MCI-186

moderate hepatic impairment

EXPERIMENTAL
Drug: MCI-186

normal hepatic function

EXPERIMENTAL
Drug: MCI-186

Interventions

MCI-186DRUG

30 mg of edaravone will be administered intravenously over 60 minutes

Also known as: Edaravone, Radicut
mild hepatic impairmentmoderate hepatic impairmentnormal hepatic function

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Investigational site

Fukuoka, Japan

Location

Investigational site

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 32800532DERIVED

MeSH Terms

Interventions

Edaravone

Intervention Hierarchy (Ancestors)

AntipyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Clinical Trials, Information Desk
Organization
Tanabe Pharma Corporation
cti-inq-ml.JP@ml.tanabe-pharma.com
Please Email

Study Officials

  • General Manager

    Tanabe Pharma Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 20, 2017

Study Start

November 16, 2016

Primary Completion

July 20, 2018

Study Completion

July 24, 2018

Last Updated

January 8, 2026

Results First Posted

February 28, 2020

Record last verified: 2025-12

Locations

JP(2)