Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-02 @ 6:41 PM
Study NCT ID:
NCT06547502
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2024-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects with Renal Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2024-08-07', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC0-inf', 'timeFrame': 'Day1-Day29'}, {'measure': 'AUC0-last', 'timeFrame': 'Day1-Day29'}, {'measure': 'Cmax', 'timeFrame': 'Day1-Day29'}], 'secondaryOutcomes': [{'measure': 'Incidence of TEAE', 'timeFrame': 'Day1-Day29'}, {'measure': 'AUC0-168h', 'timeFrame': 'Day1-Day29'}, {'measure': 'Tmax', 'timeFrame': 'Day1-Day29'}, {'measure': 'T1/2', 'timeFrame': 'Day1-Day29'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GZR4', 'kidney'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney impairment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent\n* Meeting the pre-defined Glomerular Filtration Rate (GFR) values\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to trial product\n* Drugs known to affect creatinine clearance including cimetidine within 14 days or 5 half-lives prior to the day of dosing of GZR4 and during this trial\n* Individuals who routinely undergo dialysis or have a history of renal transplantation, hepatorenal syndrome, or acute kidney injury'}, 'identificationModule': {'nctId': 'NCT06547502', 'briefTitle': 'Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects with Renal Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gan and Lee Pharmaceuticals, USA'}, 'officialTitle': 'The Study of Pharmacokinetics and Safety of a Single Dose of GZR4 Injection in Subjects with Mild to Moderate Renal Impairment and Subjects with Normal Renal Function', 'orgStudyIdInfo': {'id': 'GZR4-T2D-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal renal function', 'description': 'GFR between 90-130 ml/min', 'interventionNames': ['Drug: GZR4']}, {'type': 'EXPERIMENTAL', 'label': 'Mildly decreased renal function', 'description': 'GFR between 60-90 ml/min', 'interventionNames': ['Drug: GZR4']}, {'type': 'EXPERIMENTAL', 'label': 'moderately decreased renal function', 'description': 'GFR between 30-60 ml/min', 'interventionNames': ['Drug: GZR4']}], 'interventions': [{'name': 'GZR4', 'type': 'DRUG', 'description': 'single dose', 'armGroupLabels': ['Mildly decreased renal function', 'Normal renal function', 'moderately decreased renal function']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Site 1', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gan and Lee Pharmaceuticals, USA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}