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| Name | Class |
|---|---|
| The First Affiliated Hospital of Bengbu Medical University | OTHER |
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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%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group One A(mild hepatic impairment group) | Experimental | 10 participants with mild hepatic impairment (Child-Pugh A, score 5-6). |
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| Group Two B(moderate hepatic impairment group) | Experimental | 10 participants with moderate hepatic impairment (Child-Pugh Class B, score of 7-9). |
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| Group Three C(control group, normal hepatic function group) | Experimental | Matched 10 healthy participants with normal hepatic function will serve as the control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydronidone capsules | Drug | A single oral dose of 90 mg of the investigational drug (3 Hydronidone capsules) under fasting conditions, administered with 240 mL of water. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter of Hydronidone: Cmax | Within 48 hours of administration | |
| Pharmacokinetic Parameter of Hydronidone: AUC0-t | Within 48 hours of administration | |
| Pharmacokinetic Parameter of Hydronidone:AUC0-∞ | Within 48 hours of administration | |
| Pharmacokinetic Parameter of Hydronidone:Tmax | Within 48 hours of administration | |
| Pharmacokinetic Parameter of Hydronidone:t1/2 | Within 48 hours of administration | |
| Pharmacokinetic Parameter of Hydronidone:λz | Within 48 hours of administration | |
| Pharmacokinetic Parameter of Hydronidone:CL/F | Within 48 hours of administration | |
| Pharmacokinetic Parameter of Hydronidone:MRT | Within 48 hours of administration | |
| Pharmacokinetic Parameter of Hydronidone:Vz/F | Within 48 hours of administration | |
| Pharmacokinetic Parameter of Hydronidone:Ratio of free drugsRatio of free drugs | Within 48 hours of administration | |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: Cmax (Metabolic Ratio). | Within 48 hours after administration | |
| Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: AUC₀-t, (Metabolic Ratio). | Within 48 hours after administration |
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Inclusion Criteria:
Participants with hepatic impairment due to pre-existing primary liver disease, classified as Child-Pugh Class A (score of 5-6) or Class B (score of 7-9) at screening. They must not have received albumin infusion within 14 days prior to screening and must have a confirmed diagnosis of stable (≥1 month) hepatic impairment based on medical history, physical examination, laboratory tests, or imaging studies.
Participants have not taken any medication within 1 week prior to screening, or for those requiring long-term treatment for hepatic impairment and/or other comorbidities, their medication regimen must have been stable for at least 4 weeks (stability is judged by the investigator, excluding medications prohibited by the protocol).
Exclusion Criteria:
History of liver transplantation.
Drug-induced liver injury.
Acute liver injury due to any cause.
Cholestatic liver disease.
Liver failure with any of the following complications: uncontrolled infection; grade 3/4 hepatic encephalopathy.
Severe complications of cirrhosis with any of the following: active bleeding from esophageal or gastric varices; severe/advanced ascites or pleural effusion requiring paracentesis or drainage and albumin supplementation; hepatorenal syndrome; or any other condition deemed by the investigator as unsuitable for study participation.
Participants with poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg) or heart rate >120 bpm (allow two repeat measurements).
Any history of severe disease other than the primary liver disease itself, or any medical history or clinically significant abnormal laboratory findings considered by the investigator as likely to affect the trial results, including but not limited to history of circulatory, endocrine, neurological, digestive, urinary, hematological, immunological, psychiatric, or metabolic disorders.
Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5 times the upper limit of normal (ULN) at screening.
Supplementary Exclusion Criteria for Participants with Normal Hepatic Function (Exclusion if any one of the following criteria is met):
Positive for anti-hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg).
History of primary disease of vital organs, including but not limited to neurological/psychiatric, cardiovascular, gastrointestinal, respiratory, urinary, endocrine, hematological, or immune system diseases, deemed by the investigator as unsuitable for trial participation.
History of hepatic impairment, or any screening examination results (including physical examination, vital signs, complete blood count, urinalysis, blood biochemistry, coagulation function, 12-lead ECG, chest X-ray posteroanterior view, abdominal ultrasound, etc.) considered by the investigator as clinically significant abnormalities.
Age not within the range of the mean age of participants with mild/moderate hepatic impairment ±10 years, and/or BMI not within the range of the mean BMI of participants with mild/moderate hepatic impairment ±10%.
-Supplementary Exclusion Criteria for Participants with Normal Hepatic Function (Exclusion if any one of the following criteria is met):
Positive for anti-hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg).
History of primary disease of vital organs, including but not limited to neurological/psychiatric, cardiovascular, gastrointestinal, respiratory, urinary, endocrine, hematological, or immune system diseases, deemed by the investigator as unsuitable for trial participation.
History of hepatic impairment, or any screening examination results (including physical examination, vital signs, complete blood count, urinalysis, blood biochemistry, coagulation function, 12-lead ECG, chest X-ray posteroanterior view, abdominal ultrasound, etc.) considered by the investigator as clinically significant abnormalities.
Age not within the range of the mean age of participants with mild/moderate hepatic impairment ±10 years, and/or BMI not within the range of the mean BMI of participants with mild/moderate hepatic impairment ±10%.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Ling, Dr | Contact | +86-13501209210 | zhangling@bjcontinent.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical University | Bengbu | Anhui | China |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C000621986 | hydronidone |
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| Difference in the main parameters AUC₀-t between patients with hepatic impairment and participants with normal hepatic function. |
| Within 48 hours of administration |
| Difference in the main parameters AUC₀-∞ between patients with hepatic impairment and participants with normal hepatic function. | Within 48 hours of administration |
| Difference in the main parameters Cmax between patients with hepatic impairment and participants with normal hepatic function. | Within 48 hours of administration |
| Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: MR (Metabolic Ratio). | Within 48 hours after administration |
| Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: AUC₀-∞, (Metabolic Ratio). | Within 48 hours after administration |
| Plasma Pharmacokinetic Parameters of Metabolites M3 andM4:Tmax(Metabolic Ratio). | Within 48 hours after administration |
| Plasma Pharmacokinetic Parameters of Metabolites M3 and M4: t₁/₂(Metabolic Ratio). | Within 48 hours after administration |
| D013568 |
| Pathological Conditions, Signs and Symptoms |