Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-30 @ 9:13 AM
Study NCT ID:
NCT04066712
Status:
COMPLETED
Last Update Posted:
2020-09-21
First Post:
2019-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal PK Study of LC350189
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}, {'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2019-08-20', 'studyFirstSubmitQcDate': '2019-08-22', 'lastUpdatePostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC from time 0 to the last quantifiable concentration', 'timeFrame': 'Before dosing on Days 1 through Day 8', 'description': 'Pharmacokinetic Assessments'}, {'measure': 'AUC from time 0 to 24 hours post dose', 'timeFrame': 'Before dosing on Days 1 through Day 8', 'description': 'Pharmacokinetic Assessments'}, {'measure': 'AUC from time 0 to the end of the dosing interval at steady state', 'timeFrame': 'Before dosing on Days 1 through Day 8', 'description': 'Pharmacokinetic Assessments'}, {'measure': 'Maximum observed plasma concentration', 'timeFrame': 'Before dosing on Days 1 through Day 8', 'description': 'Pharmacokinetic Assessments'}, {'measure': 'Maximum observed plasma concentration at steady state', 'timeFrame': 'Before dosing on Days 1 through Day 8', 'description': 'Pharmacokinetic Assessments'}, {'measure': 'Time to reach maximum observed plasma concentration', 'timeFrame': 'Before dosing on Days 1 through Day 8', 'description': 'Pharmacokinetic Assessments'}, {'measure': 'Time to reach maximum observed plasma concentration at steady state', 'timeFrame': 'Before dosing on Days 1 through Day 8', 'description': 'Pharmacokinetic Assessments'}, {'measure': 'Amount of drug excreted in urine (Ae) over each collection interval', 'timeFrame': 'Before dosing on Days 1 through Day 8', 'description': 'Pharmacokinetic Assessments'}], 'secondaryOutcomes': [{'measure': 'Serum mean concentration over 24 hours', 'timeFrame': 'Before dosing on Days 1 through Day 8', 'description': 'Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)'}, {'measure': 'Maximum observed effect', 'timeFrame': 'Before dosing on Days 1 through Day 8', 'description': 'Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)'}, {'measure': 'Time to reach maximum effect', 'timeFrame': 'Before dosing on Days 1 through Day 8', 'description': 'Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Days 1 through Day 9 (end of study)', 'description': 'Safety'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gout', 'Hyperuricemia']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, open-label, parallel-group, multiple-dose study designed to assess the effect of renal impairment on the PK and PD of LC350189.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* The subject has a BMI of 18 to 40 kg/m2, inclusive, at screening.\n* The subject is able to provide written informed consent.\n\nFor healthy subjects only : The subject has normal renal function as determined by eGFR and calculated using the MDRD formula, or by 24-hour urine creatinine clearance (CLcr) corrected for body size.\n\nFor subjects with renal impairment only\n\n: The subject has mild, moderate, or severe renal impairment as determined by eGFR and calculated using the MDRD formula.\n\nExclusion Criteria\n\n* The subject has a history or clinical manifestations of a significant neurological, cardiovascular, endocrine, gastrointestinal, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator.\n* The subject has nephrotic syndrome, defined as serum albumin \\<3.0 g/dL and urine protein/creatinine ratio \\>350 mg/mmol (as an estimate of approximate proteinuria of \\>3.5 g/day) at screening.'}, 'identificationModule': {'nctId': 'NCT04066712', 'briefTitle': 'Renal PK Study of LC350189', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Chem'}, 'officialTitle': 'A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LC350189 in Subjects With Varying Degrees of Renal Impairment', 'orgStudyIdInfo': {'id': 'LG-GDCL003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A: Normal (control) renal function', 'interventionNames': ['Drug: LC350189 200 mg']}, {'type': 'EXPERIMENTAL', 'label': 'B: Mild impairment renal function', 'interventionNames': ['Drug: LC350189 200 mg']}, {'type': 'EXPERIMENTAL', 'label': 'C: Moderate impairment renal function', 'interventionNames': ['Drug: LC350189 200 mg']}, {'type': 'EXPERIMENTAL', 'label': 'D: Severe impairment renal function', 'interventionNames': ['Drug: LC350189 200 mg']}], 'interventions': [{'name': 'LC350189 200 mg', 'type': 'DRUG', 'description': 'Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7', 'armGroupLabels': ['A: Normal (control) renal function', 'B: Mild impairment renal function', 'C: Moderate impairment renal function', 'D: Severe impairment renal function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Chem', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}