Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT04993404
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2021-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics Of Jaktinib In Subjects With Hepatic Impairment And Normal Hepatic Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-09', 'studyFirstSubmitDate': '2021-07-23', 'studyFirstSubmitQcDate': '2021-07-28', 'lastUpdatePostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Jaktinib and its metabolites（ZG0244 and ZG0245）', 'timeFrame': 'From day 1 to day 3', 'description': 'To evaluate Maximum Observed Plasma Concentration (Cmax) of Jaktinib and its metabolites（ZG0244 and ZG0245）'}, {'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', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs) and Serious AEs', 'timeFrame': 'Screening up to follow-up (7 days after dose administration)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Insufficiency', 'Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '39442386', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to comprehend and willing to sign an informed consent form. Ability to comply with trial and follow-up procedures.\n* Age 18-79 years at the time of signing the ICF, either male or female.\n* 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.\n* After physical examination, vital signs, laboratory examinations, 12-lead electrocardiogram examination, the investigator determined that it is suitable to participate in this study.\n* Subjects are willing to take effective contraceptive measures from screening to 3 months after administration.\n\nAdditional Inclusion Criteria for Hepatic Impaired Subjects Only:\n\n* 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.\n* Any examination such as B-ultrasound, CT, MRI, FibroScan or liver biopsy confirms the presence of cirrhosis.\n\nAdditional Inclusion Criteria for Healthy Subjects Only:\n\n* 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.\n\nExclusion Criteria:\n\n* Drug-induced liver injury.\n* Acute liver damage caused by various reasons.\n* 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.\n* Patients with a history of massive bleeding from esophageal varices without band ligation, sclerosing agent and TIPS treatment\n* Subjects with suspected allergies to Jaktinib or its excipient.\n* History of blood donation of 400 mL or more of blood within 3 months prior to screening.\n* Drug dependency, a positive urine drug screen.\n* Subjects with any significant clinical and laboratory abnormalities which may affect the safety evaluation.\n* Subjects suffering from arrhythmia and requiring treatment, or QTcB \\> 480ms at screening.\n* Subjects with clinical symptoms of active bacterial, viral, parasitic or fungal infections requiring treatment at screening.\n* Subjects with known human immunodeficiency virus (HIV),\n* Subjects with epilepsy or patients who have received psychotropic drug or sedatives during screening.\n* 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).\n* Subjects who have participated in another clinical trial of a new drug or medical instrument within 3 months before screening.\n* Females who are breastfeeding or pregnant at Screening.\n\nExclusion Criteria for Healthy Subjects Only:\n\n* Subjects with hepatitis B surface antigen positive or HCV-RNA positive.\n* Patients with a history of liver dysfunction, or physical examination and laboratory examination at screening indicate that there is or may have liver dysfunction.'}, 'identificationModule': {'nctId': 'NCT04993404', 'briefTitle': 'Pharmacokinetics Of Jaktinib In Subjects With Hepatic Impairment And Normal Hepatic Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd'}, 'officialTitle': 'Study To Evaluate The Pharmacokinetics Of Jaktinib Hydrochloride Tablets In Subjects With Hepatic Impairment And Normal Hepatic Function', 'orgStudyIdInfo': {'id': 'ZGJAK021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A：Mild Hepatic Impairment', 'description': '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.', 'interventionNames': ['Drug: Jaktinib Hydrochloride Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B：Moderate Hepatic Impairment', 'description': '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.', 'interventionNames': ['Drug: Jaktinib Hydrochloride Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort C：Normal Hepatic Function', 'description': '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.', 'interventionNames': ['Drug: Jaktinib Hydrochloride Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort D：Severe Hepatic Impairment', 'description': '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.', 'interventionNames': ['Drug: Jaktinib Hydrochloride Tablets']}], 'interventions': [{'name': 'Jaktinib Hydrochloride Tablets', 'type': 'DRUG', 'otherNames': ['Jaktinib'], 'description': 'A single oral dose of 100 mg Jaktinib Hydrochloride Tablets will be administered.', 'armGroupLabels': ['Cohort A：Mild Hepatic Impairment', 'Cohort B：Moderate Hepatic Impairment', 'Cohort C：Normal Hepatic Function', 'Cohort D：Severe Hepatic Impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'overallOfficials': [{'name': 'Liyan Miao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}, {'name': 'Weifeng Zhao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}