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

Primary Purpose

Hepatic 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 Hepatic 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

Hepatic impaired subjects (in addition)

  • A Child-Pugh score of 5 or 6 for subjects with mild hepatic impairment, and between 7 and 9, inclusive, for subjects with moderate hepatic impairment
  • Chronic and stable hepatic impairment

Healthy subjects (in addition)

  • Subject with normal hepatic function
  • 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 drug abuse
  • Presence of alcohol abuse
  • Presence of active infection requiring antibiotics
  • Positive test for human immunodeficiency virus (HIV) antigen/antibody
  • Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>160 mmHg and/or diastolic blood pressure (DBP)>100 mmHg
  • eGFR <60 mL/min/1.73m2

Hepatic impairment subject (in addition)

  • Subjects with severe ascites

Healthy subject (in addition)

  • History or presence of any parenchymal hepatic disease
  • Positive test for hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCVAb)

Sites / Locations

  • Investigational site
  • Investigational site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

mild hepatic impairment

moderate hepatic impairment

normal hepatic 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
NCT03289234
Brief Title
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
Official Title
A Multi-Center, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 16, 2016 (Actual)
Primary Completion Date
July 20, 2018 (Actual)
Study Completion Date
July 24, 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 Hepatic impairment compared to subjects with normal hepatic function

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic 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
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mild hepatic impairment
Arm Type
Experimental
Arm Title
moderate hepatic impairment
Arm Type
Experimental
Arm Title
normal hepatic 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 Hepatic impaired subjects (in addition) A Child-Pugh score of 5 or 6 for subjects with mild hepatic impairment, and between 7 and 9, inclusive, for subjects with moderate hepatic impairment Chronic and stable hepatic impairment Healthy subjects (in addition) Subject with normal hepatic function 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 drug abuse Presence of alcohol abuse Presence of active infection requiring antibiotics Positive test for human immunodeficiency virus (HIV) antigen/antibody Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>160 mmHg and/or diastolic blood pressure (DBP)>100 mmHg eGFR <60 mL/min/1.73m2 Hepatic impairment subject (in addition) Subjects with severe ascites Healthy subject (in addition) History or presence of any parenchymal hepatic disease Positive test for hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCVAb)
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
Fukuoka
Country
Japan
Facility Name
Investigational site
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32800532
Citation
Nakamaru Y, Kakubari M, Yoshida K, Akimoto M, Todorovic V, Greis T, Kondo K. Open-label, Single-dose Studies of the Pharmacokinetics of Edaravone in Subjects with Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects with Normal Hepatic Functioning. Clin Ther. 2020 Aug;42(8):1467-1482.e4. doi: 10.1016/j.clinthera.2020.06.016. Epub 2020 Aug 14.
Results Reference
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Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment

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