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CompletedNCT03289208Updated Jul 15, 2026Results posted

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

A Phase 1 interventional study of MCI-186 in Renal Impairment and Healthy, sponsored by Shionogi. Completed at 1 site 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
30
Allocation
Non-randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Impairment
  • Healthy

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03

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

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

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 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
  • Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>160 mmHg and/or diastolic blood pressure (DBP)>100 mmHg
04

Study design

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

Study arms

  • Experimental
    mild renal impairment

    Drug: MCI-186

  • Experimental
    moderated renal impairment

    Drug: MCI-186

  • Experimental
    normal renal function

    Drug: MCI-186

Interventions

  • DrugMCI-186

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

    Also known as: Edaravone, Radicut

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. 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

06

Results

Posted Feb 28, 2020

Participant flow

Participant flow — Overall Study
MilestoneMild Renal Function GroupModerate Renal Function GroupNormal Renal Function Group
Started11811
Completed10811
Not completed100
Withdrew: Adverse event100

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/mLMild Renal Function GroupModerate Renal Function GroupNormal Renal Function Group
Cmax545.4 ± 92.59593.2 ± 115.4475.9 ± 95.32
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/mLMild Renal Function GroupModerate Renal Function GroupNormal Renal Function Group
AUC0-last758 ± 148.09808.7 ± 152.01638.09 ± 151.98
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/mLMild Renal Function GroupModerate Renal Function GroupNormal Renal Function Group
AUC0-∞770.97 ± 153.63826.44 ± 149.44644.85 ± 153.14
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
hourMild Renal Function GroupModerate Renal Function GroupNormal Renal Function Group
t½5.38 ± 6.047.31 ± 5.832.87 ± 0.38

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Mild Renal Function Group0/11 (0%)0/11 (0%)5/11 (45.5%)
Moderate Renal Function Group0/8 (0%)0/8 (0%)0/8 (0%)
Normal Renal Function Group0/11 (0%)0/11 (0%)1/11 (9.1%)
Most frequent other events
Most frequent other events
EventMild Renal Function GroupModerate Renal Function GroupNormal Renal Function Group
HeadacheNervous system disorders2/110/80/11
BronchitisInfections and infestations1/110/80/11
VomittingGastrointestinal disorders1/110/80/11
HaematuriaRenal and urinary disorders1/110/80/11
Aspartate aminotransferase increasedInvestigations0/110/81/11
Blood bilirubin increasedInvestigations1/110/80/11

Baseline characteristics

Age, Continuous
Age, Continuous(years)Mild Renal Function GroupModerate Renal Function GroupNormal Renal Function GroupTotal
Mean35.5 ± 5.157.9 ± 8.447.3 ± 4.345.8 ± 10.6
Sex: Female, Male
Sex: Female, Male(Participants)Mild Renal Function GroupModerate Renal Function GroupNormal Renal Function GroupTotal
Female5229
Male66921
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Mild Renal Function GroupModerate Renal Function GroupNormal Renal Function GroupTotal
American Indian or Alaska Native0000
Asian1181130
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White0000
More than one race0000
Unknown or Not Reported0000
07

Study locations

1 site
  • Investigational site
    Tokyo, Japan
08

References and documents

Publications

  • 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. PubMed 32868037 ↗

Study documents

  • Study protocol · Apr 2, 2018
  • Statistical analysis plan · Jun 20, 2018

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

09

Registry details

Key details

Study ID
NCT03289208
Lead sponsor
Shionogi
Responsible party
Sponsor
First posted
Sep 20, 2017
Start date
Oct 27, 2016
Primary completion
Apr 16, 2018
Completion
Apr 20, 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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