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

NCT03289208 | Completed Phase 1 Results

• 1 other identifier: MCI-186-J22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Renal Impairment; Healthy

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 renal impairment

EXPERIMENTAL

Drug: MCI-186

moderated renal impairment

EXPERIMENTAL

Drug: MCI-186

normal renal function

EXPERIMENTAL

Drug: MCI-186

Interventions

MCI-186 DRUG

30 mg of edaravone will be administered intravenously over 60 minutes.

Also known as: Edaravone, Radicut

mild renal impairment; moderated renal impairment; normal renal function

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• Renal impaired subjects (in addition)
• Subjects with mild renal impairment defined as eGFR 60-89 mL/min/1.73m2 and subjects with moderate renal impairment defined as eGFR 30-59 mL/min/1.73m2
• Chronic and stable renal impairment
• Healthy subjects (in addition)
• Subject with normal renal function defined as eGFR≥90 mL/min/1.73m2
• 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 alcohol abuse or drug abuse
• Presence of active infection requiring antibiotics
• Positive test for human immunodeficiency virus (HIV) antigen/antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (HCVAb)
• Renal impairment subject (in addition)
• Acute renal failure
• History of renal transplantation
• Aspartate aminotransferase (AST) activity, or an alanine aminotransferase (ALT) activity of at least 3 times the upper limit of normal (ULN) range
• Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)\>180 mmHg and/or diastolic blood pressure (DBP)\>110 mmHg
• Start of any new medication or new any changes to a current dosage
• Healthy subject (in addition)
• History or presence of any renal disease

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Investigational site

Tokyo, Japan

Location

Related Publications (1)

• Nakamaru Y, Kakubari M, Yoshida K, Akimoto M, Kondo K. An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Variables of Edaravone in Subjects with Mild, Moderate, or No Renal Impairment. Clin Ther. 2020 Sep;42(9):1699-1714. doi: 10.1016/j.clinthera.2020.06.020. Epub 2020 Aug 28.

  PMID: 32868037 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Edaravone

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antipyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic 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: October 27, 2016
• Primary Completion: April 16, 2018
• Study Completion: April 20, 2018
• Last Updated: January 8, 2026
• Results First Posted: February 28, 2020

Record last verified: 2025-12

Locations

JP (1)