Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-27 @ 12:25 PM
Study NCT ID:
NCT06993168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-28
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate Effect of Food of DA-5222 in Healthy Adult Subjects
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', 'interventionModelDescription': 'DA-5222'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2025-05-19', 'studyFirstSubmitQcDate': '2025-05-19', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCt', 'timeFrame': 'pre-dose~72 hours post-dose', 'description': 'area under the curve'}, {'measure': 'Cmax', 'timeFrame': 'pre-dose~72 hours post-dose', 'description': 'maximum plasma concentration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the effect of food on pharmacokinetics of DA-5222 in healthy adult subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* BMI between 18 and 30 kg/m2\n* Body weight: Male≥50kg, Female≥45kg\n* Subjects who have signed an informed consent themselves after receiving detailed explanation about clinical study\n\nExclusion Criteria:\n\n* Subjects with clinically significant medical history\n* Subjects with history of drug abuse or addicted\n* Subjects with allergy or drug hypersensitivity'}, 'identificationModule': {'nctId': 'NCT06993168', 'briefTitle': 'To Evaluate Effect of Food of DA-5222 in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of DA-5222 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'DA5222_FE_I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'interventionNames': ['Drug: DA-5222']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B', 'interventionNames': ['Drug: DA-5222']}], 'interventions': [{'name': 'DA-5222', 'type': 'DRUG', 'description': 'single dose administration (DA-5222 one tablet once a day)', 'armGroupLabels': ['Sequence A', 'Sequence B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'South Korea', 'country': 'South Korea', 'contacts': [{'name': 'Taegon Hong, Ph.D', 'role': 'CONTACT', 'email': 'tghong@bumin.co.kr'}], 'facility': 'Bumin Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jihyun Sung', 'role': 'CONTACT', 'email': 'jhsung@donga.co.kr', 'phone': '+82-02-920-8369'}, {'name': 'Heechan Jung', 'role': 'CONTACT', 'email': 'hcjung@donga.co.kr', 'phone': '+82-02-920-8322'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}