Pharmacokinetics Of Jaktinib In Subjects With Hepatic Impairment And Normal Hepatic Function

NCT ID: NCT04993404

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-27
• Study Completion Date: 2022-09-19

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).

Conditions

Hepatic Insufficiency; Healthy Subjects

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Tablets

Intervention Type: DRUG

A single oral dose of 100 mg Jaktinib Hydrochloride Tablets will be administered.

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.

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Tablets

Intervention Type: DRUG

A single oral dose of 100 mg Jaktinib Hydrochloride Tablets will be administered.

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.

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Tablets

Intervention Type: DRUG

A single oral dose of 100 mg Jaktinib Hydrochloride Tablets will be administered.

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.

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Tablets

Intervention Type: DRUG

A single oral dose of 100 mg Jaktinib Hydrochloride Tablets will be administered.

Interventions

Jaktinib Hydrochloride Tablets

A single oral dose of 100 mg Jaktinib Hydrochloride Tablets will be administered.

Intervention Type: DRUG

Other Intervention Names

Jaktinib

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.

• 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.

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liyan Miao, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Weifeng Zhao, PhD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

References

Zhao M, Zhang H, Ma S, Gong S, Wei C, Miao L, Zhao W. Clinical pharmacokinetic characteristics of Jaktinib in subjects with hepatic impairment in a phase I trial. Drug Metab Pharmacokinet. 2024 Dec;59:101030. doi: 10.1016/j.dmpk.2024.101030. Epub 2024 Jul 20.

Reference Type: DERIVED

PMID: 39442386 (View on PubMed)

Other Identifiers

ZGJAK021

Identifier Type: -

Identifier Source: org_study_id