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

Primary Purpose

Renal Impairment, Healthy

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
MCI-186
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Impairment

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Investigational site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

mild renal impairment

moderated renal impairment

normal renal function

Arm Description

Outcomes

Primary Outcome Measures

Cmax
AUC0-last
AUC0-∞

Secondary Outcome Measures

t½

Full Information

First Posted
September 19, 2017
Last Updated
April 3, 2023
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03289208
Brief Title
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2016 (Actual)
Primary Completion Date
April 16, 2018 (Actual)
Study Completion Date
April 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment, Healthy

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mild renal impairment
Arm Type
Experimental
Arm Title
moderated renal impairment
Arm Type
Experimental
Arm Title
normal renal function
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MCI-186
Other Intervention Name(s)
Edaravone, Radicut
Intervention Description
30 mg of edaravone will be administered intravenously over 60 minutes.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
General Manager
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32868037
Citation
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.
Results Reference
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Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Renal Impairment

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