How the body handles TQ05105 in people with liver impairment and healthy volunteers

Trial details

Who runs it

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Trial code

NCT07480824

Record updated

6 April 2026

Original description

This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQ05105 tablet in patients with hepatic impairment after a single dose, and to evaluate the safety of the drug in these patients after a single dose.Read full original descriptionShow less

Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of TQ05105 in Participants With Mild Hepatic Impairment (Child-Pugh A), Moderate Hepatic Impairment (Child-Pugh B), and Healthy Subjects

This is an open, open-label, parallel, single-dose, phase I clinical study designed to evaluate the pharmacokinetic (PK) profile of TQ05105 tablet in patients with hepatic impairment after a single dose, and to evaluate the safety of the drug in these patients after a single dose.

Inclusion: Voluntarily participate in the clinical trial and sign the informed consent form, with full understanding of the trial content, procedures, and potential adverse reactions; Patients (including partners) have no pregnancy plans or sperm/egg donation plans from screening until 6 months after the last dose of the investigational drug, and agree to use effective contraception; Aged 18-75 years (inclusive), regardless of gender; Male participants weigh ≥50.0 kg; female participants weigh ≥45.0 kg. Body mass index (BMI) = weight (kg)/height² (m²), with BMI ranging 18.0-32.0 kg/m² (inclusive); Patients can communicate effectively with investigators and comply with the trial protocol; Additional Criteria for Participants with Normal Liver Function:; Negative serum HBsAg and Hepatitis C Virus (HCV) antibody test results; Weight within ±10 kg of the average weight of groups A/B; age within ±10 years of the average age of groups A/B; gender distribution similar to groups A/B (±1 participant per gender); Additional Criteria for Participants with Impaired Liver Function:; Chronic liver injury caused by primary liver diseases (e.g., hepatitis B/C, non-alcoholic fatty liver disease, alcoholic liver disease) or clinically diagnosed cirrhosis, classified as Child-Pugh Grade A or B; Stable condition within 2 weeks prior to dosing as judged by the investigator; No medication within 4 weeks before screening, or stable treatment regimen for underlying diseases (including liver-protective therapy).

Exclusion: Conditions affecting drug absorption, distribution, metabolism, or excretion (e.g., dysphagia) or prior gastrointestinal resection impacting these processes; Use of strong/moderate CYP3A4, CYP2C9, or CYP2C19 inducers/inhibitors within 4 weeks before screening; Average daily smoking >5 cigarettes within 3 months before screening; Drug abuse history or positive urine drug screen within 3 months; Blood donation/loss ≥200 mL or plasmapheresis within 4 weeks before screening; Pregnant/lactating women, positive pregnancy test, or unprotected sex within 2 weeks before screening; Use of prescription/non-prescription drugs, herbal medicines, or supplements (e.g., vitamins) within 2 weeks before screening; Patients in other drug trials within 3 months or 5 half-lives (whichever longer) before screening; Additional Exclusions for Impaired Liver Function Participants:; Patients with hepatic coma within 30 days before screening; Patients who had used drugs that might cause acute hepatotoxicity (such as halothane and methotrexate) within 3 months before screening; Patients with acute liver disease caused by drug or viral infection within 2 months before screening; Who participated in and used any investigational drug within 1 month before screening; History or current diagnosis of severe/chronic diseases (e.g., digestive, respiratory, neurological, cardiovascular, hematological, endocrine, oncological, immunological, or psychiatric disorders) deemed unsuitable by the investigator (except primary liver diseases and complications in participants with impaired liver function); Known hypersensitivity to TQ05105 tablet components or allergic constitution (e.g., allergy to ≥2 substances, drug allergy history, or prone to rash/eczema/asthma); For alcoholic liver disease participants: history of excessive drinking (>2 alcohol units/day) within 1 year; for others: such history within 3 months; Positive HIV antibody or Treponema pallidum-specific antibody; Had a history of liver transplantation; With biliary cirrhosis, liver/bile duct obstruction, cholestatic liver disease and other diseases affecting biliary excretion; Patients with liver failure or liver cancer, or patients with a history of esophagogastric variceal bleeding, hepatic encephalopathy, severe portal hypertension, or a portasystemic shunt within 1 year before screening who were judged by the investigator to be ineligible for the trial; Creatinine clearance (CLcr) <60 mL/min; The results of physical examination during the screening period, vital signs, clinical laboratory tests (blood cell analysis (five categories), blood biochemistry, coagulation function, urine routine examination with sediment), electrocardiogram, frontal and lateral chest X-rays, abdominal ultrasound (liver, gallbladder, pancreas, spleen), and urinary system ultrasound, etc., which showed abnormal results and were determined by the research doctor to have clinical significance; Patients with abnormal physical examination, vital signs, clinical laboratory tests (blood cell analysis (five classification), blood biochemistry, coagulation function, urine routine and sediment), AFP, electrocardiogram, chest X-ray, echocardiography, abdominal ultrasound (liver, gallbladder, pancreas and spleen), urinary ultrasound, and routine electroencephalogram (EEG) during the screening period and judged by the research doctors as not suitable for the study; Consumption of alcohol (or positive breath test), grapefruit juice, coffee, tea, cola, or chocolate within 48 hours before dosing; Other factors deemed unsuitable by the investigator; Additional Exclusions for Normal Liver Function Participants:; Patients with massive ascites on ultrasound during the screening period who were assessed by the investigators as not suitable for the trial.

ClinicalTrials.gov NCT07480824