Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:09 AM
Study NCT ID:
NCT07319559
Status:
COMPLETED
Last Update Posted:
2026-01-06
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics of DW5124 and DW5124-R, and the Effect of Food on DW5124 in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2025-12-22', 'lastUpdatePostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': 'up to 72 hour', 'description': 'Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'up to 72 hour', 'description': 'Pharmacokinetics of DW5124-fed and DW5124-fasting, Pharmacokinetics of DW5124-fed and DW5124-R-fed'}], 'secondaryOutcomes': [{'measure': 'Time to maximum plasma concentration (Tmax)', 'timeFrame': 'up to 72 hour', 'description': 'Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed'}, {'measure': 'Terminal half life (t1/2)', 'timeFrame': 'up to 72 hour', 'description': 'Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed'}, {'measure': 'Apparent clearance (CL/F)', 'timeFrame': 'up to 72 hour', 'description': 'Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed'}, {'measure': 'Apparent volume of distribution (Vd/F)', 'timeFrame': 'up to 72 hour', 'description': 'Pharmacokinetics of DW5124-fed, DW5124-fasting, DW5124-R-fed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mixed Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the safety and pharmacokinetic characteristics of DW5124 and DW5124-R, and the effect of food on DW5124, in healthy adult volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Volunteers who are ≥19 years and \\>65 years old\n* Body weight ≥50.0 kg and BMI between 18.0 and 30.0 kg/m2\n\nExclusion Criteria:\n\n* Clinically significant Medical History\n* In the case of women, pregnant(Urine-HCG positive) or lactating women'}, 'identificationModule': {'nctId': 'NCT07319559', 'briefTitle': 'Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics of DW5124 and DW5124-R, and the Effect of Food on DW5124 in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Clinical Trial to Evaluate the Safety, Pharmacokinetic Characteristics of DW5124 and DW5124-R, and the Effect of Food on DW5124 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'DW5124-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence A', 'description': 'cross-over', 'interventionNames': ['Drug: DW5124', 'Drug: DW5124-R']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence B', 'description': 'cross-over', 'interventionNames': ['Drug: DW5124', 'Drug: DW5124-R']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence C', 'description': 'cross-over', 'interventionNames': ['Drug: DW5124', 'Drug: DW5124-R']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence D', 'description': 'cross-over', 'interventionNames': ['Drug: DW5124', 'Drug: DW5124-R']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence E', 'description': 'cross-over', 'interventionNames': ['Drug: DW5124', 'Drug: DW5124-R']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence F', 'description': 'cross-over', 'interventionNames': ['Drug: DW5124', 'Drug: DW5124-R']}], 'interventions': [{'name': 'DW5124', 'type': 'DRUG', 'description': 'DW5124 on fasted or fed condition', 'armGroupLabels': ['Sequence A', 'Sequence B', 'Sequence C', 'Sequence D', 'Sequence E', 'Sequence F']}, {'name': 'DW5124-R', 'type': 'DRUG', 'description': 'DW5124-R on fasted or fed condition', 'armGroupLabels': ['Sequence A', 'Sequence B', 'Sequence C', 'Sequence D', 'Sequence E', 'Sequence F']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cheongju-si', 'country': 'South Korea', 'facility': 'Chungbuk National University Hospital', 'geoPoint': {'lat': 36.63722, 'lon': 127.48972}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}