Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT06248567
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2024-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of ZSP1273 in Participants With Severe Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000721066', 'term': 'ZSP1273'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-18', 'studyFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2024-01-31', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': '0~120hours', 'description': 'The Cmax of a single dose of ZSP1273 in participants with severe impaired renal function and controls with normal renal function will be evaluated and compared.'}, {'measure': 'Area under the concentration-time curve from time zero to last time of quantifiable concentration (AUClast)', 'timeFrame': '0~120hours', 'description': 'The AUClast of a single dose of ZSP1273 in participants with severe impaired renal function and controls with normal renal function will be evaluated and compared.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with drug-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'DAY1~DAY12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Impairment']}, 'referencesModule': {'references': [{'pmid': '40757817', 'type': 'DERIVED', 'citation': 'Li H, Yang X, Zhang J, Chen L, Zhou M, Li Y, Liu X, Huang J, Huang J. Pharmacokinetics, safety, and tolerability of onradivir in participants with severe renal impairment and matched healthy control participants. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0046225. doi: 10.1128/aac.00462-25. Epub 2025 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the effect of severe kidney impairment on the pharmacokinetics (PK), safety and tolerability of ZSP1273.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Body mass index (BMI) ≥18 to ≤28kg/m2 and total body weight \\>50 kg(male) or \\>40kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);\n2. Ability to understand and willingness to sign a written informed consent form;\n\n Participants with normal renal function only:\n3. Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant.\n4. Glomerular filtration rate (GFR)≥ 90 mL/min\n5. Age, BMI, and sex comparable to those of subjects of severe renal impairment\n\n Participants with severe renal impairment only:\n6. Diagnosis of CKD (any indicators of renal impairment or GFR \\< 60 mL/min/1.73 m2 for more than 3 months)\n7. glomerular filtration rate (GFR) between 15-29 mL/min (including boundary)\n\nExclusion Criteria:\n\n1. Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product.\n2. Participants who donated blood or bleeding profusely (\\> 400 mL) in the 3 months.\n3. Pregnant or lactating women, or women of childbearing age with a positive pregnancy test\n4. Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks\n\n Participants with severe renal impairment only:\n5. Participants with acute renal failure, or a kidney transplant history; or requiring renal dialysis during the study period;\n6. Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm Hg or diastolic blood pressure ≥ 100mm Hg)\n7. New York heart association (NYHA) class III or IV congestive heart failure\n8. Alanine aminotransferase (ALT) ≥ 2×ULN, aspartate aminotransferase(AST) ≥ 2×ULN; Serum total bilirubin \\> 1.5×ULN;'}, 'identificationModule': {'nctId': 'NCT06248567', 'briefTitle': 'Pharmacokinetics of ZSP1273 in Participants With Severe Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangdong Raynovent Biotech Co., Ltd'}, 'officialTitle': 'A Phase I Single Dose, Non-Randomised, Open-Label, Parallel Group Study to Investigate the Effect of Severe Kidney Impairment on the Pharmacokinetics, Safety and Tolerability of ZSP1273', 'orgStudyIdInfo': {'id': 'ZSP1273-23-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental 1: participants with severe renal impairment', 'description': '8 participants with severe renal impairment will be given 600mg of ZSP1273', 'interventionNames': ['Drug: ZSP1273']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental 2: healthy participants', 'description': '8 participants with normal renal function will be given 600mg of ZSP1273', 'interventionNames': ['Drug: ZSP1273']}], 'interventions': [{'name': 'ZSP1273', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['Experimental 1: participants with severe renal impairment', 'Experimental 2: healthy participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Xiamen', 'country': 'China', 'facility': 'The First Affiliated Hospital of Xiamen University', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Raynovent Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}