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

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03289208
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
17.7
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official 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
Actual Study Start Date :
Oct 27, 2016
Actual Primary Completion Date :
Apr 16, 2018
Actual Study Completion Date :
Apr 20, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: mild renal impairment

Drug: MCI-186
30 mg of edaravone will be administered intravenously over 60 minutes.
Other Names:
  • Edaravone
  • Radicut

    		•
    Experimental: moderated renal impairment

    Drug: MCI-186
    30 mg of edaravone will be administered intravenously over 60 minutes.
    Other Names:
  • Edaravone
  • Radicut

    		•
    Experimental: normal renal function

    Drug: MCI-186
    30 mg of edaravone will be administered intravenously over 60 minutes.
    Other Names:
  • Edaravone
  • Radicut

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cmax [pre-dose to 48 hours post-dose]

    2. AUC0-last [pre-dose to 48 hours post-dose]

    3. AUC0-∞ [pre-dose to 48 hours post-dose]

    Secondary Outcome Measures

    1. t½ [pre-dose to 48 hours post-dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    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:

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational site Tokyo Japan

    Sponsors and Collaborators

    • Mitsubishi Tanabe Pharma Corporation

    Investigators

    • Study Director: General Manager, Mitsubishi Tanabe Pharma Corporation

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT03289208
    Other Study ID Numbers:
    • MCI-186-J22
    First Posted:
    Sep 20, 2017
    Last Update Posted:
    Feb 28, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Renal Insufficiency
    Edaravone

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Mild Renal Function Group Moderate Renal Function Group Normal Renal Function Group
    Arm/Group Description Mild renal function defined as eGFR 60-89 mL/min/1.73m^2 Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2 Normal renal function defined as eGFR ≥90 mL/min/1.73m^2
    Period Title: Overall Study
    STARTED 11 8 11
    COMPLETED 10 8 11
    NOT COMPLETED 1 0 0

    Baseline Characteristics

    Arm/Group Title Mild Renal Function Group Moderate Renal Function Group Normal Renal Function Group Total
    Arm/Group Description Mild renal function defined as eGFR 60-89 mL/min/1.73m^2 Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2 Normal renal function defined as eGFR ≥90 mL/min/1.73m^2 Total of all reporting groups
    Overall Participants 11 8 11 30
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    35.5
    (5.1)
    57.9
    (8.4)
    47.3
    (4.3)
    45.8
    (10.6)
    Sex: Female, Male (Count of Participants)
    Female
    5
    45.5%
    2
    25%
    2
    18.2%
    9
    30%
    Male
    6
    54.5%
    6
    75%
    9
    81.8%
    21
    70%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    11
    100%
    8
    100%
    11
    100%
    30
    100%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    White
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Cmax
    Description
    Time Frame pre-dose to 48 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    PK population
    Arm/Group Title Mild Renal Function Group Moderate Renal Function Group Normal Renal Function Group
    Arm/Group Description Mild renal function defined as eGFR 60-89 mL/min/1.73m^2 Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2 Normal renal function defined as eGFR ≥90 mL/min/1.73m^2
    Measure Participants 6 8 8
    Mean (Standard Deviation) [ng/mL]
    545.4
    (92.59)
    593.2
    (115.4)
    475.9
    (95.32)
    2. Primary Outcome
    Title AUC0-last
    Description
    Time Frame pre-dose to 48 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    PK population
    Arm/Group Title Mild Renal Function Group Moderate Renal Function Group Normal Renal Function Group
    Arm/Group Description Mild renal function defined as eGFR 60-89 mL/min/1.73m^2 Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2 Normal renal function defined as eGFR ≥90 mL/min/1.73m^2
    Measure Participants 6 8 8
    Mean (Standard Deviation) [ng*hr/mL]
    758
    (148.09)
    808.7
    (152.01)
    638.09
    (151.98)
    3. Primary Outcome
    Title AUC0-∞
    Description
    Time Frame pre-dose to 48 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    PK population
    Arm/Group Title Mild Renal Function Group Moderate Renal Function Group Normal Renal Function Group
    Arm/Group Description Mild renal function defined as eGFR 60-89 mL/min/1.73m^2 Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2 Normal renal function defined as eGFR ≥90 mL/min/1.73m^2
    Measure Participants 6 8 8
    Mean (Standard Deviation) [ng*hr/mL]
    770.97
    (153.63)
    826.44
    (149.44)
    644.85
    (153.14)
    4. Secondary Outcome
    Title t½
    Description
    Time Frame pre-dose to 48 hours post-dose

    Outcome Measure Data

    Analysis Population Description
    PK population
    Arm/Group Title Mild Renal Function Group Moderate Renal Function Group Normal Renal Function Group
    Arm/Group Description Mild renal function defined as eGFR 60-89 mL/min/1.73m^2 Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2 Normal renal function defined as eGFR ≥90 mL/min/1.73m^2
    Measure Participants 6 8 8
    Mean (Standard Deviation) [hour]
    5.38
    (6.04)
    7.31
    (5.83)
    2.87
    (0.38)

    Adverse Events

    Time Frame 7 Day as TEAE
    Adverse Event Reporting Description
    Arm/Group Title Mild Renal Function Group Moderate Renal Function Group Normal Renal Function Group
    Arm/Group Description Mild renal function defined as eGFR 60-89 mL/min/1.73m^2 Moderate renal function defined as eGFR 30-59 mL/min/1.73m^2 Normal renal function defined as eGFR ≥90 mL/min/1.73m^2
    All Cause Mortality
    Mild Renal Function Group Moderate Renal Function Group Normal Renal Function Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/11 (0%) 0/8 (0%) 0/11 (0%)
    Serious Adverse Events
    Mild Renal Function Group Moderate Renal Function Group Normal Renal Function Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/11 (0%) 0/8 (0%) 0/11 (0%)
    Other (Not Including Serious) Adverse Events
    Mild Renal Function Group Moderate Renal Function Group Normal Renal Function Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/11 (45.5%) 0/8 (0%) 1/11 (9.1%)
    Gastrointestinal disorders
    Vomitting 1/11 (9.1%) 0/8 (0%) 0/11 (0%)
    Infections and infestations
    Bronchitis 1/11 (9.1%) 0/8 (0%) 0/11 (0%)
    Investigations
    Aspartate aminotransferase increased 0/11 (0%) 0/8 (0%) 1/11 (9.1%)
    Blood bilirubin increased 1/11 (9.1%) 0/8 (0%) 0/11 (0%)
    Nervous system disorders
    Headache 2/11 (18.2%) 0/8 (0%) 0/11 (0%)
    Renal and urinary disorders
    Haematuria 1/11 (9.1%) 0/8 (0%) 0/11 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/Title Clinical Trials, Information Desk
    Organization Mitsubishi Tanabe Pharma Corporation
    Phone Please Email
    Email cti-inq-ml@ml.mt-pharma.co.jp
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT03289208
    Other Study ID Numbers:
    • MCI-186-J22
    First Posted:
    Sep 20, 2017
    Last Update Posted:
    Feb 28, 2020
    Last Verified:
    Feb 1, 2020