Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
Study NCT ID:
NCT04305392
Status:
UNKNOWN
Last Update Posted:
2022-08-10
First Post:
2020-03-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720748', 'term': 'ruzinurad'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2020-03-10', 'studyFirstSubmitQcDate': '2020-03-10', 'lastUpdatePostDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': '72 hours after dosing', 'description': 'Peak Plasma Concentration (Cmax) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients'}, {'measure': 'Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity (AUC0-∞)', 'timeFrame': '72 hours after dosing', 'description': 'Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity (AUC0-∞) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Impairment']}, 'descriptionModule': {'briefSummary': 'Study to evaluate pharmacokinetics, pharmacodynamics and safety of SHR4640 in patients with mild, moderate hepatic impairment and normal liver function in phase I clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nAll subjects:\n\n* Signing the informed consent forms.\n* 18 years to 65 years (inclusive).\n* Body mass index should be between 18 and 30 kg/m2 (inclusive).\n* No medication was used before screening#or stable medication for 4 weeks.\n\nNormal liver function:\n\n• Clinical laboratory tests during the screening period were normal or the abnormality has no clinical significance.\n\nHepatic impaired subjects:\n\n* Child-Pugh Classification score clinically determined as mild or moderate hepatic impairment.\n* Liver damage due to primary liver disease.\n\nExclusion Criteria:\n\n\\-\n\nAll subjects:\n\n• Subject known or suspected of being sensitive to the study drugs or its ingredient.\n\nNormal liver function:\n\n* Previous history of liver function impairment, or physical examination and laboratory examination at screening indicated the presence or possibility of liver function impairment.\n* Hepatitis B surface antigen (HBsAg) positive or Anti-hepatitis C virus (HCV) antibody or hepatitis C core antigen positive within 3 months prior to administration.\n\nHepatic impaired subjects:\n\n* Suspected or diagnosed as liver cancer or with other malignant tumors.\n* Drug induced liver injury#acute liver injury#liver transplantation history.\n* Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.'}, 'identificationModule': {'nctId': 'NCT04305392', 'briefTitle': 'Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment (Multicenter, Single Dose, Parallel, Open)', 'orgStudyIdInfo': {'id': 'SHR4640-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal liver function', 'description': 'Patients will receive single dose of SHR4640', 'interventionNames': ['Drug: SHR4640']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Hepatic Impairment', 'description': 'Patients will receive single dose of SHR4640', 'interventionNames': ['Drug: SHR4640']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Hepatic Impairment', 'description': 'Patients will receive single dose of SHR4640', 'interventionNames': ['Drug: SHR4640']}], 'interventions': [{'name': 'SHR4640', 'type': 'DRUG', 'description': 'orally SHR4640', 'armGroupLabels': ['Mild Hepatic Impairment', 'Moderate Hepatic Impairment', 'Normal liver function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100069', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Meixia Wang', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}