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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Healthy

Treatments: Drug: MCI-186

Study type: Interventional

Funder types: Industry

Identifiers

NCT03289234

MCI-186-J23

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

mild hepatic impairment

Experimental group

Treatment:

Drug: MCI-186

moderate hepatic impairment

Experimental group

Treatment:

Drug: MCI-186

normal hepatic function

Experimental group

Treatment:

Drug: MCI-186