Status:
COMPLETED
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Hepatic Impairment
Healthy
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 16 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03289234
Start Date
November 16 2016
End Date
July 24 2018
Last Update
January 8 2026
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational site
Fukuoka, Japan
2
Investigational site
Tokyo, Japan