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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-27

Study Completion Date

2018-04-20

Brief Summary

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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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Detailed Description

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Conditions

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Renal Impairment Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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mild renal impairment

Group Type EXPERIMENTAL

MCI-186

Intervention Type DRUG

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

moderated renal impairment

Group Type EXPERIMENTAL

MCI-186

Intervention Type DRUG

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

normal renal function

Group Type EXPERIMENTAL

MCI-186

Intervention Type DRUG

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

Interventions

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MCI-186

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

Intervention Type DRUG

Other Intervention Names

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Edaravone Radicut

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes