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

CompletedPhase 1

Sponsor: Shionogi

Conditions: Hepatic Impairment, Healthy

Interventions: MCI-186

Countries: Japan

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

Eligibility overview

Sex: ALL

Age: 20 Years to 75 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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)

Locations (2)

Fukuoka, Japan
Tokyo, Japan