pharmacokinetics of jaktinib in subjects with hepatic impairment and normal hepatic function

Conditions: Hepatic Insufficiency; Healthy Subjects

Summary: 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).


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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.