Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT06354556
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2024-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Verapamil Tablets on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002312', 'term': 'Cardiomyopathy, Hypertrophic'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001020', 'term': 'Aortic Stenosis, Subvalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014700', 'term': 'Verapamil'}], 'ancestors': [{'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single center, open, single arm, fixed sequence'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed serum concentration (Cmax) for HRS-1893 after Single dose', 'timeFrame': 'from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose'}, {'measure': 'Area under the plasma concentration versus time curve from time zero to last measurable timepoint (AUC0-t) for HRS-1893 after single dose', 'timeFrame': 'from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose'}, {'measure': 'Area under the plasma concentration versus time curve from time zero extrapolated to infinity (AUC0-inf) for HRS-1893 after single dose', 'timeFrame': 'from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose'}], 'secondaryOutcomes': [{'measure': 'Time to maximum observed serum concentration (Tmax) for HRS-1893 after single dose', 'timeFrame': 'from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose'}, {'measure': 'Elimination half-life (T1/2) for HRS-1893 after single dose', 'timeFrame': 'from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose'}, {'measure': 'Apparent oral clearance (CL/F) for HRS-1893 after single dose', 'timeFrame': 'from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose'}, {'measure': 'Apparent volume of distribution (Vz/F) for HRS-1893 after single dose', 'timeFrame': 'from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose'}, {'measure': 'Accumulated amount of excretion (Ae) for HRS-1893 after single dose', 'timeFrame': 'from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose'}, {'measure': 'Urinary excretion fraction（fe）for HRS-1893 after single dose', 'timeFrame': 'from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose'}, {'measure': 'Renal clearance（CLr）for HRS-1893 after single dose', 'timeFrame': 'from Day 1 to Day 8 after the first dose and from Day 12 to Day 19 after the second dose'}, {'measure': 'Number of subjects with adverse events and the severity of adverse events', 'timeFrame': 'from Day 1 to Day 24 after the first dose'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this phase Ⅰ study is to evaluate the effect of oral verapamil tablets on the pharmacokinetics of HRS-1893 in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF).\n2. Male or female aged 18-55（adult healthy volunteers).\n3. Body mass index (BMI) between 19 and 28 kg/m2.\n4. Normal Electrocardiogram (ECG).\n\nExclusion Criteria:\n\n1. History of persistent tachyarrhythmia and syncope.\n2. A history of stomach or bowel surgery or excision.\n3. Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.\n4. Those who have participated in any clinical trials and have taken study drugs within 3 months before the first administration.'}, 'identificationModule': {'nctId': 'NCT06354556', 'briefTitle': 'Effect of Verapamil Tablets on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Suncadia Medicine Co., Ltd.'}, 'officialTitle': 'Effect of Verapamil on the Pharmacokinetic of HRS-1893 Tablets in Healthy Subjects: a Single Center, Open, Single Arm, and Fixed Sequence Study', 'orgStudyIdInfo': {'id': 'HRS-1893-102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'interventionNames': ['Drug: HRS-1893 tablet', 'Drug: Verapamil tablet']}], 'interventions': [{'name': 'HRS-1893 tablet', 'type': 'DRUG', 'description': 'HRS-1893 tablet single dose', 'armGroupLabels': ['Single arm']}, {'name': 'Verapamil tablet', 'type': 'DRUG', 'description': 'Verapamil tablet 80 mg tid', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Suncadia Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}