This trial adopts a single-center, single-dose, open-label, non-randomized, parallel-controlled design. It will be conducted in participants with varying degrees of hepatic impairment, as well as in participants with normal hepatic function matched for sex, age, and BMI. The administration method is a single oral dose of 90 mg hydroxynidone capsules under fasting conditions.
Participants meeting the inclusion criteria with corresponding degrees of hepatic impairment and those with normal hepatic function will be enrolled. Each group will complete the study with 10 participants. Matched participants will be comparable in terms of sex (±1 participant per sex), mean age (±10 years), and mean BMI (±10%).
Participants fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and are able to complete the entire trial process as required by the protocol.
Age between 18 and 75 years (inclusive), both males and females.
At screening, male participants weigh ≥50 kg, female participants weigh ≥45 kg, and body mass index [BMI = weight (kg) / height² (m²)] is within the range of 18 to 32 kg/m² (inclusive).
Participants and their partners agree to have no plans for conception or sperm/egg donation from the signing of the informed consent form until 6 months after the last dose of the investigational drug, and voluntarily agree to use effective contraceptive measures.
Known history of allergy to any component of the investigational product, drugs of the same class (GLP-1 receptor agonists), or their excipients; or history of allergic constitution (multiple drug and food allergies); or history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.).
Diagnosis of malignant tumor, or history of malignant tumor within 5 years prior to screening (except for: prior hepatocellular carcinoma surgery with stability ≥2 years; treated non-melanoma skin cancer with no signs of recurrence; and excised cervical intraepithelial neoplasia).
Presence of severe infection, trauma, gastrointestinal surgery, or other major surgery within 4 weeks prior to screening.
12-lead electrocardiogram (ECG) abnormalities considered clinically significant by the investigator [e.g., tachycardia/bradycardia requiring medication, II-III degree atrioventricular block, prolonged QTcF interval (male QTcF >470 ms, female QTcF >480 ms, corrected using Fridericia's formula), or other abnormalities deemed clinically significant by the physician].
Parallel
Hydronidone capsules
DrugA single oral dose of 90 mg of the investigational drug (3 Hydronidone capsules) under fasting conditions, administered with 240 mL of water.
Pharmacokinetic Parameter of Hydronidone: Cmax
Pharmacokinetic Parameter of Hydronidone: AUC0-t
Pharmacokinetic Parameter of Hydronidone:AUC0-∞
Pharmacokinetic Parameter of Hydronidone:Tmax
Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: Cmax (Metabolic Ratio).
Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: AUC₀-t, (Metabolic Ratio).
Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: MR (Metabolic Ratio).
Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: AUC₀-∞, (Metabolic Ratio).
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Beijing Continent Pharmaceutical Co, Ltd.
Lead sponsor
The First Affiliated Hospital of Bengbu Medical University
Collaborator
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