Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT06775834
Status:
COMPLETED
Last Update Posted:
2025-09-10
First Post:
2025-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics Study of HRS-1893 Tablets in Healthy Subjects and Those With Impaired Kidney Function
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'}]}}, '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': '2025-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': '0 hour to 16 days after the dosing.'}, {'measure': 'Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t)', 'timeFrame': '0 hour to 16 days after the dosing.'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)', 'timeFrame': '0 hour to 16 days after the dosing.'}], 'secondaryOutcomes': [{'measure': 'Time to reach maximum plasma concentration (Tmax)', 'timeFrame': '0 hour to 16 days after the dosing.'}, {'measure': 'Terminal half-life (t1/2)', 'timeFrame': '0 hour to 16 days after the dosing.'}, {'measure': 'Apparent clearance (CL/F)', 'timeFrame': '0 hour to 16 days after the dosing.'}, {'measure': 'Apparent volume of distribution (Vz/F)', 'timeFrame': '0 hour to 16 days after the dosing.'}, {'measure': 'Cumulative excretion (Ae)', 'timeFrame': '0 hour to 16 days after the dosing.'}, {'measure': 'Plasma protein binding rate (PPB)', 'timeFrame': '0 hour to 16 days after the dosing.'}, {'measure': 'Incidence and severity of adverse events (AEs)', 'timeFrame': '0 hour to 16 days after the dosing.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertrophic Cardiomyopathy']}, 'descriptionModule': {'briefSummary': 'The primary objective is to evaluate pharmacokinetics of HRS-1893 tablets in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial;\n2. Male or female subjects aged 18 to 65 (including 18 and 65);\n3. Body mass index (BMI) ranges from 19 kg/m2 to 28 kg/m2 (including 18 and 28);\n4. The glomerular filtration rate should meet the following criteria (GFR, mL/min): Subjects with mild renal impairment: 60-89 mL/min; Subjects with moderate renal impairment: 30-59 mL/min.\n\nExclusion Criteria:\n\n1. Suspected allergy to the study drug or any component of the study drug;\n2. Patients with cardiogenic shock, severe conduction block, sick sinus syndrome, heart failure, sustained tachyarrhythmia, torsades de pointes (Tdp) or ventricular tachycardia, history of clinically significant T wave changes, myocardial infarction, angina pectoris;\n3. People with conditions associated with reduced neuromuscular transmission (myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular dystrophy);\n4. Patients with a history of gastric or intestinal surgery that may affect drug absorption;\n5. Participants with renal insufficiency who were judged by the investigator to be ineligible for the study;\n6. Patients with large fluctuations or rapid deterioration of renal function within 2 weeks before administration, as judged by the investigator;\n7. Subjects receiving renal replacement therapy within 3 months of the screening period or during the expected trial period;\n8. Within 3 months before screening, patients with underlying diseases that induced chronic kidney disease and were poorly controlled according to the investigator's evaluation."}, 'identificationModule': {'nctId': 'NCT06775834', 'briefTitle': 'Safety and Pharmacokinetics Study of HRS-1893 Tablets in Healthy Subjects and Those With Impaired Kidney Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Suncadia Medicine Co., Ltd.'}, 'officialTitle': 'Safety and Pharmacokinetic Study of HRS-1893 Tablets in Subjects With Mild and Moderate Renal Insufficiency and Healthy Subjects', 'orgStudyIdInfo': {'id': 'HRS-1893-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal Renal Function Group', 'interventionNames': ['Drug: HRS-1893']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Renal Impairment Group', 'interventionNames': ['Drug: HRS-1893']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Renal Impairment Group', 'interventionNames': ['Drug: HRS-1893']}], 'interventions': [{'name': 'HRS-1893', 'type': 'DRUG', 'description': 'HRS-1893 tablets.', 'armGroupLabels': ['Mild Renal Impairment Group', 'Moderate Renal Impairment Group', 'Normal Renal Function Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Suncadia Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}