NCT07538973尚未招募1 期
Phase I Clinical Study to Evaluate the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects With Impaired Liver Function Versus Normal Liver Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- To determine the Cmax
研究概览
简要总结
Evaluation of the Pharmacokinetics and Safety of Anecatibin Fumarate Capsules in Subjects with Impaired Liver Function versus Normal Liver Function
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must meet all of the following inclusion criteria:
- •Provide signed informed consent prior to trial participation and have a full understanding of the trial content, procedures, and potential adverse reactions;
- •Be male or female subjects aged 18 to 65 years (inclusive);
- •Weigh at least 50 kg for males and at least 45 kg for females. Body Mass Index (BMI = weight (kg) / height² (m²)) within the range of 18 to 30 kg/m² (inclusive of boundary values);
- •Subjects and their partners agree to voluntarily adopt effective contraceptive measures from screening until 6 months after the last dose;
- •Subjects are able to communicate well with the investigators and can complete the study according to the study protocol.
- •Subjects with normal liver function must also meet the following inclusion criteria:
- •Negative test results for Hepatitis B surface antigen and Hepatitis C antibody;
- •Normal liver function test results or abnormal results without clinical significance;
- •Matched with the hepatic impairment group in terms of male-to-female ratio (±1 subject per gender), mean age (±10 years), and mean body weight (±10 kg).
- •Subjects with hepatic impairment must meet the following inclusion criteria:
- •Have a history of or be diagnosed at screening with primary liver disease, including but not limited to: Hepatitis B, Hepatitis C, non-alcoholic fatty liver disease, alcoholic liver disease, etc.;
- •Hepatic impairment is caused by a previous primary liver disease (diagnosed at least 2 weeks prior to screening; excluding oncology patients) and is classified as Child-Pugh Class A or B;
- •Liver function is stable within 2 weeks prior to taking the study drug, as determined by the investigator;
- •No medication for liver disease within 4 weeks prior to screening, or on a stable medication regimen for existing underlying conditions.
排除标准
- •All subjects who meet any of the following exclusion criteria are not eligible for enrollment:
- •Suffering from primary diseases of major organs, including but not limited to gastrointestinal, respiratory, renal, neurological, hematological, endocrine, oncological, immune, psychiatric, or cardiovascular diseases, as determined by the Investigator to be unsuitable for participation in this trial (except for hepatic impairment patients regarding their primary liver disease and complications of hepatic impairment);
- •Physical examination, vital signs, or clinical laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function) show abnormalities of clinical significance, as determined by the Investigator to be unsuitable for participation in this trial (except for hepatic impairment patients regarding their primary liver disease and complications of hepatic impairment);
- •Participated in any drug clinical trial and used any investigational drug within 3 months prior to screening;
- •Tested positive for HIV or syphilis screening;
- •Subjects with conditions that may affect the absorption, distribution, metabolism, or excretion of the study drug (e.g., inability to swallow) or who have undergone gastrointestinal resection that may affect drug absorption, distribution, metabolism, or excretion;
- •Electrocardiogram (ECG) abnormalities of clinical significance (e.g., tachycardia/bradycardia requiring medication, second- or third-degree atrioventricular block, or other abnormalities deemed clinically significant and unsuitable for participation by the Investigator);
- •Used any CYP3A4 inhibitors (e.g., macrolide antibiotics such as clarithromycin, triazole antifungals such as itraconazole, and HIV protease inhibitors such as lopinavir) or CYP3A4 inducers (e.g., rifampicin, carbamazepine, and phenytoin) within 4 weeks prior to screening;
- •Used any prescription drugs, over-the-counter medications, herbal medicines, or dietary supplements (e.g., vitamins, calcium supplements) within 2 weeks prior to screening, except for medications used by hepatic impairment patients to treat hepatic impairment and its complications;
- •Known allergy to any component of TQ-B3101 capsules, or having an allergic constitution (including a history of drug allergy, prone to rashes, eczema, urticaria, asthma, etc.);
- •Smoked an average of more than 5 cigarettes per day within 3 months prior to screening;
- •Has a history of drug abuse within 3 months prior to screening, or tested positive for urine drug screening;
- •Alcoholic liver disease patients have a history of alcoholism within 12 months prior to screening; other subjects have a history of alcoholism within 3 months prior to screening (average daily alcohol consumption > 2 units [1 unit = 360 mL beer or 45 mL 40% spirits or 150 mL wine]);
- •Donated blood or plasma, lost ≥ 200 mL of blood, or undergone plasmapheresis within 4 weeks prior to screening;
- •Consumed any food or beverage containing alcohol (or tested positive for alcohol breath test 1 day before dosing; alcoholic liver disease subjects consumed any alcohol-containing substances 2 weeks before dosing), grapefruit juice/pomelo juice, coffee, tea, cola, or chocolate within 1 week before dosing;
- •Creatinine clearance (CLcr) < 60 mL/min (calculated by the Cockcroft-Gault formula);
- •Female subjects who are lactating or test positive for pregnancy during screening or the trial period;
- •Deemed by the Investigator to have any factors making them unsuitable for participation in this trial.
- •Subjects with hepatic impairment must also meet the following additional exclusion criteria:
- •History of liver transplantation;
- •Experienced hepatic encephalopathy within 30 days prior to screening;
- •Used any medication that may cause acute hepatotoxicity (e.g., halothane and methotrexate) within 3 months prior to screening;
- •Suffered from drug- or virus-induced acute hepatitis within 2 months prior to screening;
- •Experienced a rapid deterioration or Alanine Aminotransferase/Aspartate Aminotransferase (ALT/AST) elevation > 3 times the upper limit of normal within 2 weeks prior to dosing, as judged by the Investigator;
- •Experienced worsening of hepatic encephalopathy within 30 days prior to dosing;
- •Suffering from diseases affecting bile excretion, such as biliary cirrhosis, hepatic/biliary obstruction, or cholestatic liver disease;
- •Patients with liver failure or complications deemed unsuitable by the Investigator, such as hepatic encephalopathy, hepatocellular carcinoma, esophageal-gastric variceal bleeding within 3 months, severe portal hypertension, or history of portosystemic shunt surgery;
- •As judged by the Investigator, having concomitant medications that may potentially affect the evaluation of the pharmacokinetic characteristics of TQ-B3101 and its metabolites.
研究组 & 干预措施
Anecatibin Fumarate Capsules (TQ-B3101 Capsules)
Experimental
The dose is 300 mg, administered once.
干预措施: Anecatibin Fumarate Capsules (Drug)
结局指标
主要结局
To determine the Cmax
时间窗: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
To determine the Cmax of TQ-B3101 and its benzyloxypyridine metabolites.
To determine the Area Under the Curve (AUC) 0-t
时间窗: The period extends from the date of the first dose to the completion of the end of treatment (EOT) visit, totaling 5 days
To determine the AUC 0-t of TQ-B3101 and its benzyloxypyridine metabolites.
To determine the AUC 0-∞
时间窗: The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days
To determine the AUC 0-∞ of TQ-B3101 and its benzyloxypyridine metabolites.
次要结局
- Tmax of TQ-B3101 and its benzyloxy pyridine metabolite(The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days)
- t1/2 of TQ-B3101 and its benzyloxy pyridine metabolite(The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days)
- Vz/F of TQ-B3101 and its benzyloxy pyridine metabolite(The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days)
- Apparent Clearance (CLz/F) of TQ-B3101 and its benzyloxy pyridine metabolite(The period extends from the date of the first dose to the completion of the EOT visit, totaling 5 days)
- Numbers of subjects with adverse events(The period extends from the first dose date to the completion of the safety follow-up, not to exceed 90 days)
研究者
研究点 (3)
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