This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment.
This study is a single-center, non-randomized, open-label, parallel, single-dose study to evaluate the PK profile and safety of MY008211A Tablets in subjects with hepatic impairment. It is planned to enroll 24 subjects, male or female. A total of 3 treatment groups will be set up: normal hepatic function group, mild hepatic impairment (Child-Pugh A) group, moderate hepatic impairment (Child-Pugh B) group, with 8 subjects in each group. Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions. This study will first enroll subjects in Group A (mild hepatic impairment) and Group B (moderate hepatic impairment). Age, gender and body weight will not be matched between subjects in Groups A and B; after enrollment for Groups A and B is completed, subjects will be enrolled in Group C (normal hepatic function) as control subjects matched with the hepatic impairment subjects (Group A + Group B): Subjects who sign the informed consent form (ICF) will be screened according to the inclusion/exclusion criteria. Eligible subjects will be admitted to the Clinical Research Unit (CRU) on Day -1 (D-1). On D1, they will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions and will be discharged after completing the observations and drop-out examinations on D4. They will receive a telephone follow-up on D11. During the study, sample collection, recording of adverse events (AEs), concomitant medication/non-drug therapy, physical examination, vital signs, ECG, and clinical laboratory tests will be performed according to the protocol requirements.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
24
Each subject will take a single oral dose of 400 mg MY008211A Tablets under fasting conditions.
The First Hospital of Jilin University
Jilin City, Changchun, China
Cmax
maximum concentration
Time frame: up to 12 weeks
AUC0-last
area under the plasma concentration-time curve from 0 to the last quantifiable time point
Time frame: up to 12 weeks
AUC0-inf
area under the plasma concentration-time curve from 0 to infinity
Time frame: up to 12 weeks
Tmax
time to reach maximum concentration
Time frame: up to 12 weeks
CL/F
apparent clearance
Time frame: up to 12 weeks
Vz/F
apparent volume of distribution
Time frame: up to 12 weeks
t1/2
terminal half-life
Time frame: up to 12 weeks
body temperature
Measure the body temperature of the subjects, using degrees Celsius as the unit.
Time frame: up to 12 weeks
IU/L or mIU/mL of HCG in the blood of reproductive-aged women
The blood human chorionic gonadotropin (HCG) pregnancy test will measure the concentration of HCG in the blood of reproductive-aged women to determine if they are pregnant. The units in the report will be presented in IU/L (international units per liter) and/or mIU/mL.
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Time frame: up to 12 weeks
12-lead ECG
Evaluate QT interval, PR interval, etc.
Time frame: up to 12 weeks
adverse events and serious adverse events
Time frame: up to 12 weeks
Pulse
Measure the pulse of the subjects, expressing it in units of beats per minute.
Time frame: up to 12 weeks
Blood pressure
Measure the systolic and diastolic blood pressure of the subjects, with the unit of mm/hg.
Time frame: up to 12 weeks