| Eligibility |
Inclusion Criteria:
1. Male or female participants,between the ages of 18 and 68 years of age (inclusive) at
the time of Screening;
2. Body weight =50 kg for males, =45kg for females, and body mass index (BMI)
between18-30 kg/m^2(inclusive);
3. Voluntarily sign the informed consent form, understand the trial procedures, and be
willing to comply with all trial procedures and restrictions.
Participants with Hepatic Impairment Only:
Participants must satisfy the criteria for primary liver disease as evidenced by a
Child-Pugh A (score 5-6), B (score 7-9). Treatment-naïve participants for at least 4 weeks
before screening can be entered into the study. Unless otherwise stated, participants must
have been on stable doses and regimens of the concomitant medication for at least 4 weeks
before screening.
Participants with Normal Hepatic Function Only:
1. Healthy participants, between the ages of 18 and 68 years of age (inclusive) at the
time of Screening, matched to participants with hepatic impairment with regard to age
(+/-10 years), and gender(+/-1 subject);
2. Body weight =50 kg for males, =45kg for females, and body mass index (BMI)
between18-30 kg/m^2(inclusive), matched to participants with hepatic impairment with
regard to body weight (+/-25% kg);
3. In good health, determined by no clinically significant findings from vital signs,
physical examination, 12-lead electrocardiogram (ECG), clinical laboratory
evaluations, and other safety examinations at screening, as assessed by the
investigator.
4. Men must agree to use protocol-specified contraception and also to not donate sperm
throughout the study and for at least 3 months after the final dose of study drug
5. Adequate hepatic function within 14 days before drug administration defined as: AST or
ALT = 1.5 times the upper limit of normal values, total bilirubin within normal
limits.
Exclusion Criteria:
1. History of allergic conditions or allergic diseases, or a history of allergic
reactions attributed to drugs. Those who cannot follow a uniform diet for special
dietary requirements.
2. History of seizure,including any febrile seizure, or transient ischemic attack, or any
condition that may pre-dispose to seizure (such as prior stroke, brain arteriovenous
malformation, brain trauma with requiring hospitalization, and lacunar cerebral
infarction).
3. Have a malignant tumor or a history of malignant tumor in the 5 years prior to
screening (except for patients with non-melanoma skin cancers with no evidence of
recurrence, or patients with excised cervical intraepithelial neoplasia).
4. Subjects with severe infection, trauma, gastrointestinal surgery or other major
surgical operations within 4 weeks before screening;
5. Abnormal blood pressure response, or clinically significant abnormal blood pressure
assessed by the investigator.
6. Having a history of clinically significant ECG abnormalities (history of
tachycardia/bradycardia requiring medical therapy, II-III degree atrioventricular
block, or QTcF>450ms for males,>460ms for females(corrected by Fridericia's formula),
or other clinically significant abnormals assessed by the investigator.
7. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2, according to the
modification of diet in renal disease equation.
8. Those who plan to undergo surgery, or intent to intent to be hospitalized during the
trial.
9. A positive test for HIV antibody at screening.
10. Received any drugs that inhibit or induce the CYP450 enzyme (i.e., phenytoin,
rifampin, carbamazepine, fluvoxamine, enoxacin, ticlopidine, gemfibrozil, clopidogrel,
clarithromycin, itraconazole, ketoconazole, ritonavir) 4 weeks prior to screening
period.
11. Received any drugs (including Chinese herbal medicine, vitamins and supplements)
within 14 days or 5-half-lives (which is longer) prior to dosing;
12. Participation in another clinical trial within 3 months before dosing.
13. Those who have lost blood or donated up to 200 mL within 3 months before dosing, or
those who plan to donate blood within 1 month after the end of this study.
14. Smoking more than 5 cigarettes per day within 3 months prior to screening,or who
cannot stop using any tobacco products during the study period.
15. Average weekly intake of alcohol is more than 14 units alcohol (1 units ˜ 360 mL beer,
or 45 mL spirits with 40% content, or 150 mL wine) within the 6 months prior to
dosing, or a positive ethanol breath test at screening.
16. Substance abuse or use of soft drugs (e.g., marijuana) or use of hard drugs (e.g.,
cocaine, amphetamines, phenylcyclohexidine, etc.); Or screening for positive urine
drug abuse (drug) tests.
17. Habitual or excessive consumption (more than 8 cups, 1cup=250mL) of grapefruit juice,
tea, coffee and/or caffeinated beverages.
18. Subjects who are intolerant to venipuncture or have a history of fainting blood or
acupuncture.
19. Those who have received vaccine within 1 month before screening.
20. Pregnant or lactating women, or those with positive blood pregnancy tests.
21. Male or female subjects of childbearing age agreed to take effective and safe
contraception during treatment and 3 months after treatment.
22. Subjects with poor compliance, or not suitable for this study as judged by the
investigator.
Participants with Hepatic Impairment Only:
1. Have received liver transplant at any time in the past.
2. Patients complicated with drug-induced liver injury.
3. Other causes of acute liver injury.
4. Patients with liver failure, or combined with hepatic encephalopathy, hepatocellular
carcinoma, and esophageal and gastric variceal bleeding and other complications
considered by the investigator as unsuitable for the clinical study.
5. Any history of clinically serious illness or disease or condition except for primary
liver disease that the investigator believes may affect the results of the trial,
including but not limited to a history of circulatory, endocrine, nervous, digestive,
urinary, or hematological, immune, psychiatric, and metabolic disorders.
Participants with Normal Hepatic Function Only:
1. Any history of clinically serious illness or disease or condition except for primary
liver disease that the investigator believes may affect the results of the trial,
including but not limited to a history of circulatory, endocrine, nervous, digestive,
urinary, or hematological, immune, psychiatric, and metabolic disorders.
2. Any history of hepatic impairment, or potential presence of liver function impairment
by physical examination and laboratory examination at screening.
3. Positive result of any indicators of hepatitis B surface antigen, hepatitis C antibody
within 1 week prior to screening or at screening.
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