Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT05515458
Status:
COMPLETED
Last Update Posted:
2024-05-28
First Post:
2022-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Chiglitazar in Subjects With Renal Impairment and Normal Renal Function
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': 'C515629', 'term': 'chiglitazar'}]}}, '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': '2022-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-24', 'studyFirstSubmitDate': '2022-08-23', 'studyFirstSubmitQcDate': '2022-08-23', 'lastUpdatePostDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '4 days', 'description': 'Maximum plasma concentration'}, {'measure': 'AUC0-t and AUC0-inf', 'timeFrame': '4 days', 'description': 'Area under of the curve (AUC0-t and AUC0-inf)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Impairment']}, 'descriptionModule': {'briefSummary': 'This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of Chiglitazar following administration of a single oral dose in subjects with renal impairment compared to subjects with normal renal function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily sign informed consent, able to comply with the requirements of the study.\n* Male or female, between 18 and 79 years of age.\n* 18≤BMI≤30. Weight of male ≥50 kg and Weight of female ≥ 45 kg.\n* No medication within 2 weeks, or stable medication for at least 4 weeks prior to screening.\n* the absolute eGFR must meet standard in renal function classification.\n* Physical examination, vital signs examination, 12-lead electrocardiogram (ECG) examination, and laboratory test have been determined by the investigator to be suitable for participating in this trial, and serum potassium ≥3.5 mmol/L and ≤5.5 mmol/L.\n\nExclusion Criteria:\n\n* Allergic constitution, or allergic to PPAR agonist drugs or any component of Chiglitazar tablets.\n* received PPAR agonist drugs within 2 weeks before screening.\n* Those who have been vaccinated within 4 weeks before screening, or who plan to be vaccinated during the trial.\n* positive test for COVID-19.\n* suffer from uncontrolled serious diseases of heart failure/hypertension, respiratory, liver, gastrointestinal, endocrine, blood, mental/nervous systems within 1 year before screening.\n* have previously undergone surgery that may affect the absorption, distribution, metabolism, and excretion of drugs; anticipate surgery or hospitalization during the trial.\n* Drug abusers within 5 years before screening., or positive test for drugs of abuse.\n* Smoking more than 5 cigarettes per day on average within 3 months before screening.\n* The average daily alcohol intake in the 3 months prior to screening exceeds the following criteria: more than 14 g for women, or more than 28 g for men; ingested any products containing alcohol within 48 hours before administration; positive alcohol breath test.\n* Ingestion of grapefruit juice/grapefruit juice, food or drink rich in methylxanthine within 48 hours before administration; strenuous exercise or other factors that affect drug absorption, distribution, metabolism, excretion.\n* participated in clinical trials of any drug or medical device within 3 months before screening.\n* donated blood (or blood loss) ≥400 mL within 3 months before screening, or have received blood products.\n* Acute hepatitis, chronic liver disease, or any one of ALT, AST, and total bilirubin is greater than 2 times the upper limit of normal.\n* HBsAg, HCV antibody, HIV antibody, or TP antibody antibody positive.\n* Female subjects who are breastfeeding or positive test of serum pregnancy.\n* Other circumstances assessed by the investigator are not suitable for participating in this trial.'}, 'identificationModule': {'nctId': 'NCT05515458', 'briefTitle': 'Pharmacokinetics of Chiglitazar in Subjects With Renal Impairment and Normal Renal Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chipscreen Biosciences, Ltd.'}, 'officialTitle': 'Study to Evaluate the Pharmacokinetics of Chiglitazar in Subjects With Renal Impairment and Normal Renal Function', 'orgStudyIdInfo': {'id': 'CGZ109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal Renal Function', 'description': 'Subjects with normal renal function will receive a single 48 mg oral dose of Chiglitazar', 'interventionNames': ['Drug: Chiglitazar']}, {'type': 'EXPERIMENTAL', 'label': 'Severe Renal Impairment', 'description': 'Subjects with severe renal impairment will receive a single 48 mg oral dose of Chiglitazar', 'interventionNames': ['Drug: Chiglitazar']}], 'interventions': [{'name': 'Chiglitazar', 'type': 'DRUG', 'description': 'Oral single dose 48 mg', 'armGroupLabels': ['Normal Renal Function', 'Severe Renal Impairment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'the First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'overallOfficials': [{'name': 'LiYan Miao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Suzhou Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chipscreen Biosciences, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}