Study To Evaluate The Pharmacokinetics Of Jaktinib Hydrochloride Tablets In Subjects With Hepatic Impairment And Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]of Jaktinib and its metabolites（ZG0244 and ZG0245）
研究概览
简要总结
This multi-center, open-label, parallel-controlled, single-dose Phase 1 study is being conducted to directly characterize the pharmacokinetic (PK) profiles and safety of Jaktinib following administration of a single oral dose in subjects with varying degrees of hepatic impairment compared to healthy matched control subjects with normal hepatic function(matched by age, weight, and sex).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to comprehend and willing to sign an informed consent form. Ability to comply with trial and follow-up procedures.
- •Age 18-79 years at the time of signing the ICF, either male or female.
- •Male subjects body weight at least 50 kg, and female subjects body weight at least 45 kg. Body mass index (BMI) between 18 and 32 kg/m2 to participate.
- •After physical examination, vital signs, laboratory examinations, 12-lead electrocardiogram examination, the investigator determined that it is suitable to participate in this study.
- •Subjects are willing to take effective contraceptive measures from screening to 3 months after administration.
- •Additional Inclusion Criteria for Hepatic Impaired Subjects Only:
- •Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment(Requires no use of albumin within 14 days), And it is dysfunction caused by previous primary liver disease.
- •Any examination such as B-ultrasound, CT, MRI, FibroScan or liver biopsy confirms the presence of cirrhosis.
- •Additional Inclusion Criteria for Healthy Subjects Only:
- •Have not taken any medicine within 2 weeks before administration; or have stable medication for at least 4 weeks before administration for the treatment of other comorbid diseases.
排除标准
- •Drug-induced liver injury.
- •Acute liver damage caused by various reasons.
- •Patients with liver failure, or combined with dominant hepatic encephalopathy, liver cancer, etc., which the investigator believes are not suitable for participating in the study.
- •Patients with a history of massive bleeding from esophageal varices without band ligation, sclerosing agent and TIPS treatment
- •Subjects with suspected allergies to Jaktinib or its excipient.
- •History of blood donation of 400 mL or more of blood within 3 months prior to screening.
- •Drug dependency, a positive urine drug screen.
- •Subjects with any significant clinical and laboratory abnormalities which may affect the safety evaluation.
- •Subjects suffering from arrhythmia and requiring treatment, or QTcB > 480ms at screening.
- •Subjects with clinical symptoms of active bacterial, viral, parasitic or fungal infections requiring treatment at screening.
- •Subjects with known human immunodeficiency virus (HIV),
- •Subjects with epilepsy or patients who have received psychotropic drug or sedatives during screening.
- •Subjects who had experienced malignant tumors within the past 5 years (except for adequately treated local basal cell carcinoma of the skin and cervical carcinoma in situ that have been cured).
- •Subjects who have participated in another clinical trial of a new drug or medical instrument within 3 months before screening.
- •Females who are breastfeeding or pregnant at Screening.
- •Exclusion Criteria for Healthy Subjects Only:
- •Subjects with hepatitis B surface antigen positive or HCV-RNA positive.
- •Patients with a history of liver dysfunction, or physical examination and laboratory examination at screening indicate that there is or may have liver dysfunction.
研究组 & 干预措施
Cohort A：Mild Hepatic Impairment
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) will be administered a single dose of Jaktinib Hydrochloride Tablets.
干预措施: Jaktinib Hydrochloride Tablets (Drug)
Cohort B：Moderate Hepatic Impairment
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) will be administered a single dose of Jaktinib Hydrochloride Tablets.
干预措施: Jaktinib Hydrochloride Tablets (Drug)
Cohort C：Normal Hepatic Function
Participants with normal hepatic function matched to participants with hepatic impairment in Cohorts A and B (matched with regards to age, sex, body mass index) will be administered a single oral dose of Jaktinib Hydrochloride Tablets.
干预措施: Jaktinib Hydrochloride Tablets (Drug)
Cohort D：Severe Hepatic Impairment
Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 11, inclusive) will be administered a single dose of Jaktinib Hydrochloride Tablets.
干预措施: Jaktinib Hydrochloride Tablets (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]of Jaktinib and its metabolites（ZG0244 and ZG0245）
时间窗: From day 1 to day 3
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Maximum Observed Plasma Concentration (Cmax) of Jaktinib and its metabolites（ZG0244 and ZG0245）
时间窗: From day 1 to day 3
To evaluate Maximum Observed Plasma Concentration (Cmax) of Jaktinib and its metabolites（ZG0244 and ZG0245）
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of Jaktinib and its metabolites（ZG0244 and ZG0245）
时间窗: From day 1 to day 3
The AUC (0-infinity) is the area under the plasma Jaktinib and its metabolites（ZG0244 and ZG0245）concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z)
次要结局
- Number of Participants with Adverse Events (AEs) and Serious AEs(Screening up to follow-up (7 days after dose administration))