Clinical trial NCT04993404: Pharmacokinetics Of Jaktinib In Subjects With Hepatic Impairment And Normal Hepatic Function
Official title: Study To Evaluate The Pharmacokinetics Of Jaktinib Hydrochloride Tablets In Subjects With Hepatic Impairment And Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Insufficiency
Healthy Subjects
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]of Jaktinib and its metabolites（ZG0244 and ZG0245）
timeFrame: From day 1 to day 3
measure: Maximum Observed Plasma Concentration (Cmax) of Jaktinib and its metabolites（ZG0244 and ZG0245）
timeFrame: From day 1 to day 3
measure: 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）
timeFrame: From day 1 to day 3
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Serious AEs
timeFrame: Screening up to follow-up (7 days after dose administration)
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Liyan Miao, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Soochow University
name: Weifeng Zhao, PhD
role: PRINCIPAL_INVESTIGATOR
References: