Hepatic Impairment
Conditions
Interventions
Mild hepatic impairment:D-2570 9mg
Moderate hepatic impairment:D-2570 9mg
Normal hepatic function subjects matched to subjects with hepatic impairment:D-2570 9mg
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily agree to participate in this study after fully informed consent, sign the written informed consent form, and agree to comply with the procedures specified in the study protocol; 2. Aged 18 to 70 years (inclusive) (age matching between the normal hepatic function group and the hepatic insufficiency group, mean +- 10 years); 3. Both males and females are eligible (gender matching between the normal hepatic function group and the hepatic insufficiency group, +-1 case); 4. Male participants weigh no less than 50 kg, female participants weigh no less than 45 kg. Body Mass Index (BMI) = body weight (kg) / height^2 (m^2), BMI within the range of 19 to 30 kg/m^2 (inclusive) (weight matching between the normal hepatic function group and the hepatic insufficiency group, mean +- 10 kg); 5. Participants with hepatic insufficiency must meet: (1) Chronic hepatic insufficiency caused by primary liver diseases (e.g., viral hepatitis, autoimmune hepatitis, alcoholic liver disease, etc.), with Child-Pugh classification of Gr; 6. Participants with hepatic insufficiency must meet: Have not taken any medication within 2 weeks prior to study drug administration; or have been on stable medication for at least 4 weeks for the treatment of hepatic insufficiency and/or other comorbidities prior to study drug administration, and no dosage adjustment is expected during the study period (as determined by the investigator); 7. Participants with normal hepatic function must meet: Normal results in vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, abdominal color Doppler ultrasound (liver, gallbladder, spleen, pancreas, both kidneys) and chest X-ray (anteroposterior view), or abnormalities that are judged by the investigator to have no clinical significance; 8. Participants with hepatic insufficiency must meet: Results of vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, abdominal color Doppler ultrasound (liver, gallbladder, spleen, pancreas, both kidneys) and chest X-ray (anteroposterior view) are judged by the investigator to be suitable for participation in this study, and screening laboratory test results meet the following criteria: a) Routine blood test: absolute neutrophil count >= 0.75 × 10^9/L, hemoglobin (HGB) >= 90 g/L, platelet count >= 30 × 10^9/L; b) Blood biochemistry: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 40%; 9. Creatinine clearance >= 60 mL/min; 10. No plans for pregnancy or sperm/egg donation from the start of screening until 30 days after the last dose of study drug, and agree to practice complete abstinence or use effective contraceptive measures from the start of screening until 30 days after the last dose of study drug;
Exclusion criteria
Exclusion criteria: 1. History of chronic hepatitis (e.g., hepatitis B, hepatitis C, etc.), or history of hepatic impairment, or those with physical examination, abdominal color Doppler ultrasound or laboratory tests at screening suggesting the presence or possible presence of hepatic impairment (participants with normal hepatic function); 2. Drug-induced liver injury (participants with hepatic insufficiency); 3. Participants with hepatic insufficiency who have any of the following conditions and are assessed by the investigator as unsuitable for this trial shall be excluded: (1) Previous liver transplantation; (2) Previous partial hepatectomy; (3) Suspected or confirmed liver cancer or other malignant tumors (except for specific cancers that have been surgically resected and completely cured, such as basal cell carcinoma or squamous cell carcinoma of the skin, or cervical carcinoma in situ); (4) Patients with liver failure; (5) Those with esophageal and gastric variceal bleeding within 3 months before screening; (6) Patients with diseases that severely affect bile excretion, such as biliary cirrhosis, biliary obstruction, cholestatic liver disease, etc.; (7) Those with overt hepatic encephalopathy or severe ascites, hepatorenal syndrome; (8) Those with severe portal hypertension or previous portosystemic shunt, including transjugular intrahepatic portosystemic shunt (TIPS); 4. Allergic constitution (e.g., allergy to pollen, two or more drugs/foods), or history of specific allergic diseases (asthma, urticaria) or known allergy to D-2570 tablets or their excipients; 5. Positive T-SPOT test result during screening period, combined with the participant's clinical signs, chest anteroposterior X-ray, etc., judged by the investigator as active pulmonary tuberculosis; 6. History of herpes zoster/herpes simplex, or presence of herpes zoster/herpes simplex during screening period; 7. Previous history of severe diseases of the respiratory, circulatory, digestive, urinary, hematological, endocrine, nervous systems, metabolic abnormalities and infections, or current presence of the above diseases (except for primary liver diseases and complications in patients with hepatic insufficiency), or new-onset diseases before study drug administration, assessed by the investigator as unsuitable for this trial; 8. Various factors affecting oral administration and drug absorption (such as inability to swallow/dysphagia, postoperative gastrointestinal resection, ulcerative colitis, symptomatic/inflammatory bowel disease, chronic diarrhea and intestinal obstruction and other gastrointestinal diseases); 9. Previous surgery that may affect drug absorption, distribution, metabolism, and excretion, judged by the investigator as unsuitable for enrollment; 10. Those who cannot tolerate venipuncture/indwelling needle blood collection or have needle phobia/hemophobia; 11. Alpha-fetoprotein (AFP) > 50 ng/mL at screening; 12. Prolonged QT interval corrected by Fridericia's method (QTcF) on 12-lead ECG during screening period (QTcF > 470 ms, Fridericia's correction formula: QTcF = QT/RR^0.33), or previous history of QT interval prolongation, or family history of long QT syndrome or familial arrhythmia (e.g., pre-excitation syndrome, sudden cardiac death, etc.); 13. Female participants who are breastfeeding during screening or during the trial, or have positive serum pregnancy test results; 14. Hepatitis B surface antigen (HBsAg) positive with positive hepatitis B DNA test or viral load highe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma pharmacokinetic (PK) parameters of D-2570 and its metabolites (if applicable); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactZhou Huan
The First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed