Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT03289234
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT03289234
Study Brief:
Protocol Section:
NCT03289234