Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT06916169
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-08
First Post:
2025-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Pharmacokinetics of AG2304 Compared to Coadministration of AG23041 and AG23042
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2025-04-02', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': 'Pharmacokinetic plasma samples collected over a 72-hour period', 'description': 'Area under the plasma concentration'}, {'measure': 'Cmax', 'timeFrame': 'Pharmacokinetic plasma samples collected over a 72-hour period', 'description': 'Peak Plasma Concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the pharmacokinetic characteristics of AG2304 in healthy subjects.', 'detailedDescription': 'To evaluate the pharmacokinetic characteristics and safety profiles of AG2304 compared with coadministration AG23041 and AG23042 after a single oral dose administration in healthy Korean subjects under fasting conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A healthy adults aged 19-65 years at the time of screening\n* Subjects who are deemed eligible based on the screening tests\n\nExclusion Criteria:\n\n* Subjects who have taken the investigational drug within 6 months prior to the first dose\n* Other exclusions have been applied'}, 'identificationModule': {'nctId': 'NCT06916169', 'briefTitle': 'A Study to Evaluate the Safety and Pharmacokinetics of AG2304 Compared to Coadministration of AG23041 and AG23042', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ahn-Gook Pharmaceuticals Co.,Ltd'}, 'officialTitle': 'An Open-label, Randomized, Fasting, Single, Group 2, Stage 2, Cross-over Study to Evaluate the Safety and Pharmacokinetics of AG2304 Compared to Coadministration of AG23041 and AG23042 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'AG2304 BE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'description': 'Period 1: Coadministration of AG23041 and AG23042, Period 2: AG2304', 'interventionNames': ['Drug: AG2304', 'Drug: AG23041 and AG23042']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence B', 'description': 'Period 1: AG2304, Period 2: Coadministration of AG23041 and AG23042', 'interventionNames': ['Drug: AG2304', 'Drug: AG23041 and AG23042']}], 'interventions': [{'name': 'AG2304', 'type': 'DRUG', 'description': 'AG2304, Single-dose Oral Administration', 'armGroupLabels': ['Sequence A', 'Sequence B']}, {'name': 'AG23041 and AG23042', 'type': 'DRUG', 'description': 'AG23041/AG23042, Single-dose Oral Administration', 'armGroupLabels': ['Sequence A', 'Sequence B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahn-Gook Pharmaceuticals Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}