Hepatic Insufficiency, Healthy Subjects
Conditions
Brief 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).
Interventions
A single oral dose of 100 mg Jaktinib Hydrochloride Tablets will be administered.
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]of Jaktinib and its metabolites（ZG0244 and ZG0245） | 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） | 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） | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) and Serious AEs | Screening up to follow-up (7 days after dose administration) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Countries
China
Outcome results
None listed