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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289208
• Other study ID #: MCI-186-J22
• Status: Completed
• Phase: Phase 1
• Start date: October 27, 2016
• Est. completion date: April 20, 2018

Study information

• Verified date: April 2023
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 20, 2018
• Est. primary completion date: April 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Renal Impairment
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Japan	Investigational site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax		pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
Primary	AUC0-last		pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
Primary	AUC0-8		pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose
Secondary	t½		pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h and 48h post-dose