Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-27 @ 11:10 PM
Study NCT ID:
NCT04490434
Status:
UNKNOWN
Last Update Posted:
2020-07-29
First Post:
2020-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634065', 'term': 'fexuprazan'}, {'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D009288', 'term': 'Naproxen'}, {'id': 'D000077239', 'term': 'Meloxicam'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013844', 'term': 'Thiazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2020-04-24', 'studyFirstSubmitQcDate': '2020-07-27', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arm A, Cmax,ss of Celecoxib', 'timeFrame': 'Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)', 'description': 'Maximum measured plasma concentration at steady-state'}, {'measure': 'Arm A, AUCτ,ss of Celecoxib', 'timeFrame': 'Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)', 'description': 'Area under the plasma concentration-time curve'}, {'measure': 'Arm B, Cmax,ss of DWP14012', 'timeFrame': 'Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)', 'description': 'Maximum measured plasma concentration at steady-state'}, {'measure': 'Arm B, AUCτ,ss of DWP14012', 'timeFrame': 'Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)', 'description': 'Area under the plasma concentration-time curve'}, {'measure': 'Arm C, Cmax,ss of Naproxen', 'timeFrame': 'Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)', 'description': 'Maximum measured plasma concentration at steady-state'}, {'measure': 'Arm C, AUCτ,ss of Naproxen', 'timeFrame': 'Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)', 'description': 'Area under the plasma concentration-time curve'}, {'measure': 'Arm D, Cmax,ss of DWP14012', 'timeFrame': 'Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)', 'description': 'Maximum measured plasma concentration at steady-state'}, {'measure': 'Arm D, AUCτ,ss of DWP14012', 'timeFrame': 'Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 11,(0 hours (pre-dose), 0.5~48 hours)', 'description': 'Area under the plasma concentration-time curve'}, {'measure': 'Arm E, Cmax,ss of Meloxicam', 'timeFrame': 'Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)', 'description': 'Maximum measured plasma concentration at steady-state'}, {'measure': 'Arm E, AUCτ,ss of Meloxicam', 'timeFrame': 'Day 7,(0 hours (pre-dose), 1~72 hours) / Day 16,(0 hours (pre-dose), 1~72 hours)', 'description': 'Area under the plasma concentration-time curve'}, {'measure': 'Arm D, Cmax,ss of DWP14012', 'timeFrame': 'Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)', 'description': 'Maximum measured plasma concentration at steady-state'}, {'measure': 'Arm D, AUCτ,ss of DWP14012', 'timeFrame': 'Day 5,(0 hours (pre-dose), 0.5~48 hours) / Day 13,(0 hours (pre-dose), 0.5~48 hours)', 'description': 'Area under the plasma concentration-time curve'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Male Volunteers']}, 'referencesModule': {'references': [{'pmid': '38700290', 'type': 'DERIVED', 'citation': 'Won H, Kim E, Chae J, Lee H, Cho JY, Jang IJ, Chung JY, Kim MG, Lee S. Pharmacokinetic interactions between fexuprazan, a potassium-competitive acid blocker, and nonsteroidal anti-inflammatory drugs in healthy males. Clin Transl Sci. 2024 May;17(5):e13798. doi: 10.1111/cts.13798.'}]}, 'descriptionModule': {'briefSummary': 'drug-drug interaction between DWP14012 and three different kinds of NSAIDs', 'detailedDescription': 'to evaluate the safety/tolerability and pharmacokinetic drug-drug interaction between DWP14012 and three different kinds of NSAIDs in healthy male volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adult Caucasian or Japanese or Korean aged 19 to 50 (inclusive) years, at the time of screening.\n* Subjects weighing between 50 kg and 90 kg with BMI between 18 and 27 kg/m2 (inclusive) at screening visit.\n\nExclusion Criteria:\n\n* Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history\n* Those who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)\n* Those whose plasma AST (SGOT) and ALT (SGPT) exceed 1.5 times to the upper limit of the normal range in screening including additional examinations prior to randomization\n* Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration\n* Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration"}, 'identificationModule': {'nctId': 'NCT04490434', 'briefTitle': 'Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Randomized, Open-label, Multiple-dose Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetic Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'DW_DWP14012005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1, A (DWP14012/Celecoxib)', 'description': 'Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.', 'interventionNames': ['Drug: DWP14012', 'Drug: Celecoxib']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1, B (DWP14012/Celecoxib)', 'description': 'Patients treated with DWP14012, Celecoxib will be enrolled. DDI will be evaluated.', 'interventionNames': ['Drug: DWP14012', 'Drug: Celecoxib']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, C (DWP14012/Naproxen)', 'description': 'Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.', 'interventionNames': ['Drug: DWP14012', 'Drug: Naproxen']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2, D (DWP14012/Naproxen)', 'description': 'Patients treated with DWP14012, Naproxen will be enrolled. DDI will be evaluated.', 'interventionNames': ['Drug: DWP14012', 'Drug: Naproxen']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3, E (DWP14012/Meloxicam)', 'description': 'Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.', 'interventionNames': ['Drug: DWP14012', 'Drug: Meloxicam']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3, F (DWP14012/Meloxicam)', 'description': 'Patients treated with DWP14012, Meloxicam will be enrolled. DDI will be evaluated.', 'interventionNames': ['Drug: DWP14012', 'Drug: Meloxicam']}], 'interventions': [{'name': 'DWP14012', 'type': 'DRUG', 'description': 'DWP14012 40mg, bid', 'armGroupLabels': ['Cohort 1, A (DWP14012/Celecoxib)', 'Cohort 1, B (DWP14012/Celecoxib)', 'Cohort 2, C (DWP14012/Naproxen)', 'Cohort 2, D (DWP14012/Naproxen)', 'Cohort 3, E (DWP14012/Meloxicam)', 'Cohort 3, F (DWP14012/Meloxicam)']}, {'name': 'Celecoxib', 'type': 'DRUG', 'description': 'Celecoxib 200mg, bid', 'armGroupLabels': ['Cohort 1, A (DWP14012/Celecoxib)', 'Cohort 1, B (DWP14012/Celecoxib)']}, {'name': 'Naproxen', 'type': 'DRUG', 'description': 'Naproxen 500mg, bid', 'armGroupLabels': ['Cohort 2, C (DWP14012/Naproxen)', 'Cohort 2, D (DWP14012/Naproxen)']}, {'name': 'Meloxicam', 'type': 'DRUG', 'description': 'Meloxicam 15mg, qd', 'armGroupLabels': ['Cohort 3, E (DWP14012/Meloxicam)', 'Cohort 3, F (DWP14012/Meloxicam)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'In-Jin Jang, MD, Ph.D', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jang In-Jin, MD, PhD', 'role': 'CONTACT', 'email': 'ijjang@snu.ac.kr', 'phone': '+82-2-2072-1910'}], 'overallOfficials': [{'name': 'Jang In-Jin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}