Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-02-20 @ 1:39 PM
Study NCT ID:
NCT06644404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-16
First Post:
2024-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of Drug-Drug Interactions Between DWP16001, DWC202407, and DWC202408 in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729921', 'term': 'Enavogliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-14', 'studyFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2024-10-14', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax,ss of DWP16001', 'timeFrame': '0-24 hours', 'description': 'Peak Plasma Concentration at steady-state'}, {'measure': 'AUCtau,ss of DWP16001', 'timeFrame': '0-24 hours', 'description': 'Area under the plasma concentration versus time curve at Tau, steady-state'}, {'measure': 'Cmax,ss of DWC202407', 'timeFrame': '0-12 hours', 'description': 'Peak Plasma Concentration at steady-state'}, {'measure': 'AUCtau,ss of DWC202407', 'timeFrame': '0-12 hours', 'description': 'Area under the plasma concentration versus time curve at Tau, steady-state'}, {'measure': 'Cmax,ss of DWC202408', 'timeFrame': '0-24 hours', 'description': 'Peak Plasma Concentration at steady-state'}, {'measure': 'AUCtau,ss of DWC202408', 'timeFrame': '0-24 hours', 'description': 'Area under the plasma concentration versus time curve at Tau, steady-state'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the pharmacokinetic/pharmacodynamic drug-drug interactions between DWP16001, DWC202407, and DWC202408 in healthy adults', 'detailedDescription': 'This study aims to evaluate the pharmacokinetic interactions, pharmacodynamic interactions, safety, and tolerability of DWP16001, DWC202407, and DWC202408 in healthy adults'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adult volunteers aged 19 to 50 years at the time of screening.\n2. Individuals with a body weight between 50.0 kg and 90.0 kg and a Body Mass Index (BMI) between 18.5 kg/m² and 29.9 kg/m² at the time of screening.\n3. Female volunteers must be neither pregnant nor breastfeeding, or must be in a surgically sterile state (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy).\n4. Individuals who have been fully informed about the clinical trial, have fully understood the details, voluntarily decided to participate, and provided written consent to comply with the precautions.'}, 'identificationModule': {'nctId': 'NCT06644404', 'acronym': 'DW_DWP16001112', 'briefTitle': 'Phase 1 Study of Drug-Drug Interactions Between DWP16001, DWC202407, and DWC202408 in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Randomized, Open, Two-sequence, Crossover, Multiple Oral Administrations, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Drug-drug Interaction Between DWP16001, DWC202407, and DWC202408 in Healthy Adults', 'orgStudyIdInfo': {'id': 'DW_DWP16001112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enavogliflozin 0.3mg, once daily', 'interventionNames': ['Drug: DWP16001 0.3mg']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin 1,000mg, BID', 'interventionNames': ['Drug: DWC202407 1,000mg']}, {'type': 'EXPERIMENTAL', 'label': 'Glimepiride 2mg, once daily', 'interventionNames': ['Drug: DWC202408 2mg']}], 'interventions': [{'name': 'DWP16001 0.3mg', 'type': 'DRUG', 'description': '1 tablet, Orally, Once daily single dose', 'armGroupLabels': ['Enavogliflozin 0.3mg, once daily']}, {'name': 'DWC202407 1,000mg', 'type': 'DRUG', 'description': '1 tablet, Orally, Twice daily', 'armGroupLabels': ['Metformin 1,000mg, BID']}, {'name': 'DWC202408 2mg', 'type': 'DRUG', 'description': '1 tablet, Orally, Once daily single dose', 'armGroupLabels': ['Glimepiride 2mg, once daily']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'SeungHwan Lee', 'role': 'CONTACT', 'email': 'dayejung@daewoong.co.kr', 'phone': '+82-2-550-8317'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'DaYe Jung', 'role': 'CONTACT', 'email': 'dayejung@daewoong.co.kr', 'phone': '+82-2-550-8317'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}