Inclusion Criteria:
Participants who sign the ICF prior to the trial, have a full understanding of the trial content, procedures, and possible adverse reactions, and are able to complete the study in accordance with the protocol requirements.
* 18 years of age, male or female. BMI 19.0\~32.0 kg/m² and body weight \>50 kg of male and \>45 kg of female.
Cohort A \& C (with hepatic impairment):
Stable hepatic impairment classified as Child-Pugh Class A (mild) and B (moderate) No clinically significant worsening of hepatic status at least 2 months.
Cohort B \& D (without hepatic impairment):
BMI matched with hepatic impairment, mean ±10% Age matched with hepatic impairment, mean ±3 years Gender matched with hepatic impairment
Exclusion Criteria:
Alpha-fetoprotein (AFP) \> 20 ng/mL at screening. Current or past history of mental disorders or cerebral dysfunction; participants with suicide risk as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS); history of self-harm or suicide attempt within 1 year prior to screening; or participants deemed to be at suicide risk based on the investigator's clinical judgment.
Past or current severe diseases of the nervous system, psychiatric system, digestive system, circulatory system, respiratory system (e.g., abnormal airway anatomical structures, congenital macroglossia, mandibular dysplasia; chronic obstructive pulmonary disease, obstructive sleep apnea syndrome), urinary system or other systemic diseases, which are considered unsuitable for study participation by the investigator.
Past or current active gastrointestinal diseases and symptoms including active gastric ulcer and reflux esophagitis (e.g., heartburn, acid regurgitation), which are deemed unsuitable for enrollment by the investigator.
A history of surgeries that may affect drug absorption, distribution, metabolism and excretion (ADME), and considered unsuitable for enrollment by the investigator.
Susceptibility to allergic reactions, allergic diathesis (e.g., allergy to pollen, two or more drugs or food items), or known hypersensitivity to any ingredients of the investigational product.
Participation in any other clinical trial and administration of any investigational medicinal products or devices within 3 months prior to screening; or within 7 elimination half-lives of other study drugs at screening, whichever is longer.
Use of strong or moderate CYP3A inhibitors or inducers within 30 days prior to the first dose of investigational product (or 7 times the corresponding elimination half-life, whichever is longer).
Use of any medications that alter gastric pH within 14 days prior to the first dose of investigational product .
History of massive blood loss (\> 400 mL) or blood donation within 3 months prior to screening; or planned blood donation during the study period and within 3 months after study completion.
Significant changes in dietary or sleeping habits within 4 weeks prior to screening, which are considered unsuitable for study participation by the investigator.
Consumption of grapefruit or grapefruit-containing products within 48 hours prior to the first dose of investigational product.
Excessive intake of tea, coffee or caffeinated beverages within 3 months prior to screening (average daily intake \> 8 cups; 1 cup = 200 mL).
Average daily cigarette consumption of more than 5 cigarettes within 3 months prior to screening, or inability to abstain from all tobacco products during the study.
Regular alcohol consumption within 3 months prior to screening (i.e., more than 14 alcohol units per week; 1 unit = 14 g alcohol, equivalent to 360 mL beer, 45 mL 40% alcohol spirit, or 150 mL wine) or inability to abstain from alcoholic beverages during the study.
Intake of any alcohol-containing products within 24 hours prior to investigational product administration, or a positive breath alcohol test result.
History of substance abuse or dependence, or illicit drug use within 5 years prior to screening, or positive urine drug screen result.
Administration of albumin within 14 days prior to the first dose of investigational product.
Lactating or pregnant women; or positive serum pregnancy test with clinically significant abnormalities as judged by the investigator.
Inability to tolerate venous puncture or indwelling needle blood collection, or fear of needles or blood.
Any other conditions that may prevent the subject from completing the study, or other factors deemed unsuitable for study participation by the investigator.
Participants with normal hepatic function will be excluded if they meet any of the following criteria:
Clinically significant abnormalities identified by the investigator in physical examination, vital signs, electrocardiogram (ECG), abdominal ultrasound, chest X-ray, or clinical laboratory tests.
Positive result for any of the following at screening: hepatitis B surface antigen, anti-hepatitis C virus antibody, anti-Treponema pallidum antibody, human immunodeficiency virus (HIV) antigen/antibody.
Prolonged QT interval on 12-lead ECG at screening (QTcF \> 450 ms for males, QTcF \> 470 ms for females).
Use of any prescription drugs, over-the-counter drugs, traditional Chinese herbal medicines or dietary supplements within 14 days prior to the first dose of investigational product (excluding topically administered agents with local effects); or within 7 elimination half-lives of any prior medication, whichever is longer.
History of hepatic injury.
Participants with hepatic impairment will be excluded if they meet any of the following criteria:
Positive HIV antigen/antibody or positive anti-Treponema pallidum antibody. Positive hepatitis B surface antigen with hepatitis B viral DNA above the upper limit of detection; or positive anti-hepatitis C virus antibody with hepatitis C viral RNA above the upper limit of detection.
Further exclusion criteria apply.
