Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-25 @ 2:13 PM
Study NCT ID:
NCT04328766
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2020-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012847', 'term': 'Single Person'}, {'id': 'C000634065', 'term': 'fexuprazan'}], 'ancestors': [{'id': 'D017533', 'term': 'Marital Status'}, {'id': 'D005191', 'term': 'Family Characteristics'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-13', 'studyFirstSubmitDate': '2020-03-24', 'studyFirstSubmitQcDate': '2020-03-30', 'lastUpdatePostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma drug concentration-time curve', 'timeFrame': 'upto 48 hours postdose', 'description': 'AUClast of DWC202005'}, {'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': 'upto 48 hours postdose', 'description': 'Cmax of DWC202005'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'up to 19 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug-drug Interaction']}, 'descriptionModule': {'briefSummary': 'An open-label, multiple-dose clinical trial to evaluate the safety/tolerability and pharmacokinetic interaction between DWP14012 and DWC202005 in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults aged 19 to 50 years with BMI between 18.5 kg/m2 and 30.0 kg/m2\n* Capable of understanding provided information and complying with protocol requirements\n* Provide written informed consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT04328766', 'briefTitle': 'Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'An Open-Label, Multiple-Dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Interaction Between DWP14012 and DWC202005 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'DW_DWP14012106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DWP14012 Cohort A', 'interventionNames': ['Drug: DWC202005, alone']}, {'type': 'EXPERIMENTAL', 'label': 'DWP14012 Cohort B', 'interventionNames': ['Drug: DWP14012 + DWC202005']}, {'type': 'EXPERIMENTAL', 'label': 'DWP14012 Cohort C', 'interventionNames': ['Drug: DWP14012 + DWC202005, after multiple doses of DWP14012']}], 'interventions': [{'name': 'DWC202005, alone', 'type': 'DRUG', 'description': 'DWC202005, as a single dose', 'armGroupLabels': ['DWP14012 Cohort A']}, {'name': 'DWP14012 + DWC202005', 'type': 'DRUG', 'description': 'DWP14012 and DWC202005, as a single dose', 'armGroupLabels': ['DWP14012 Cohort B']}, {'name': 'DWP14012 + DWC202005, after multiple doses of DWP14012', 'type': 'DRUG', 'description': 'DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days', 'armGroupLabels': ['DWP14012 Cohort C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78', 'city': 'Queensland', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Nucleus Network (QPharm)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}