Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT04157959
Status:
UNKNOWN
Last Update Posted:
2019-11-08
First Post:
2019-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Drug-Drug Interaction of SHR4640 and Febuxostat in Patients With Hyperuricemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2019-11-04', 'studyFirstSubmitQcDate': '2019-11-06', 'lastUpdatePostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of SHR4640 and Febuxostat from plasma', 'timeFrame': 'Day1 to Day 14'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) of SHR4640 and Febuxostat from plasma', 'timeFrame': 'Day1 to Day 14'}], 'secondaryOutcomes': [{'measure': 'Apparent terminal half-life (t1/2) of SHR4640 and Febuxostat from plasma', 'timeFrame': 'Day1 to Day 14'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events', 'timeFrame': 'Clinical significant changes from Day-21 up to Day 29', 'description': 'Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperuricemia']}, 'referencesModule': {'references': [{'pmid': '36131360', 'type': 'DERIVED', 'citation': 'Wang C, Yu Q, Jiang X, Deng Y, Sun F, Li X, Tao Y, Lin P, Ma Y, Zhu Y, Li C, Cao Y. A Drug-Drug Interaction Study of a Novel Selective Urate Reabsorption Inhibitor, SHR4640, and Xanthine Oxidase Inhibitor, Febuxostat, in Patients With Primary Hyperuricemia. J Clin Pharmacol. 2023 Feb;63(2):239-249. doi: 10.1002/jcph.2159. Epub 2022 Oct 20.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640 and Febuxostat interaction in patients with Hyperuricemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject has a body mass index ≥18 and ≤30 kg/m2;\n2. Screening sUA value ≥8mg/dl;\n3. Subject has no clinically relevant abnormalities in vital signs, ECG, physical examination，imaging examination or safety laboratory values.\n\nExclusion Criteria:\n\n1. Subject known or suspected of being sensitive to the study drugs or its ingredient；\n2. ALT、AST、TBIL\\>ULN;\n3. History of kidney stones or screening kidney stones by B-ultrasound；\n4. History of malignancy；\n5. History of xanthinuria；\n6. Donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood。'}, 'identificationModule': {'nctId': 'NCT04157959', 'briefTitle': 'The Drug-Drug Interaction of SHR4640 and Febuxostat in Patients With Hyperuricemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Phase I, Single-Center, Open-Label Study to Evaluate Pharmacodynamics of Drug-Drug Interaction Between SHR4640 and Febuxostat in Patients With Hyperuricemia', 'orgStudyIdInfo': {'id': 'SHR4640-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR4640', 'description': 'SHR4640 dose1 Oral Tablet Day1\\~Day14 qd,Febuxostat dose2 Oral Tablet Day8 and Day14 qd.', 'interventionNames': ['Drug: SHR4640 dose1', 'Drug: Febuxostat dose2']}, {'type': 'EXPERIMENTAL', 'label': 'Febuxostat', 'description': 'Febuxostat dose2 Oral Tablet Day1 and Day14 qd, SHR4640 dose1 Oral Tablet Day8\\~Day14 qd.', 'interventionNames': ['Drug: SHR4640 dose1', 'Drug: Febuxostat dose2']}], 'interventions': [{'name': 'SHR4640 dose1', 'type': 'DRUG', 'description': 'Tablet,dose1,QD', 'armGroupLabels': ['Febuxostat', 'SHR4640']}, {'name': 'Febuxostat dose2', 'type': 'DRUG', 'description': 'Tablet,dose2,QD', 'armGroupLabels': ['Febuxostat', 'SHR4640']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cao Yu', 'role': 'CONTACT', 'email': 'Caoyu1767@126.com', 'phone': '0532-82911767'}], 'facility': 'The Affiliated Hospital of QingDao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'centralContacts': [{'name': 'Cao Yu', 'role': 'CONTACT', 'email': 'Caoyu1767@126.com', 'phone': '0532-82911767'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}