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Completed

NCT Number: NCT03289208

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

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.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Healthy Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigational site

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

MCI-186

Drug

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

Other names: Edaravone, Radicut

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

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Registry information

Official study title

An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Mild or Moderate Renal Impairment Compared to Subjects With Normal Renal Function

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 20, 2017
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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