Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
Study NCT ID:
NCT07265466
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'C522181', 'term': 'apixaban'}], 'ancestors': [{'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'None (open label)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '[Part 1] Change in P2Y12 Reaction Unit (PRU) from baseline on day 8', 'timeFrame': 'baseline on day 8', 'description': 'Change in P2Y12 Reaction Unit (PRU)'}, {'measure': '[Part 2] Emax of arachidonic acid-induced platelet aggregation', 'timeFrame': 'up to 48 hours post-dose on Day 1', 'description': 'Emax of arachidonic acid-induced platelet aggregation'}, {'measure': '[Part 2] AUEC0-24 of arachidonic acid-induced platelet aggregation', 'timeFrame': 'up to 48 hours post-dose on Day 1', 'description': 'AUEC0-24 of arachidonic acid-induced platelet aggregation'}, {'measure': '[Part 2] Cmax,ss of JP-1366', 'timeFrame': 'up to 24 hours post-dose on Day 5', 'description': 'Cmax,ss of JP-1366'}, {'measure': '[Part 2] AUCτ,ss of JP-1366', 'timeFrame': 'up to 24 hours post-dose on Day 5', 'description': 'AUCτ,ss of JP-1366'}, {'measure': '[Part 2] Cmax of Aspirin', 'timeFrame': 'up to 48 hours post-dose on Day 1', 'description': 'Cmax of Aspirin'}, {'measure': '[Part 2] AUClast of Aspirin', 'timeFrame': 'up to 48 hours post-dose on Day 1', 'description': 'AUClast of Aspirin'}, {'measure': '[Part 3] Cmax,ss of JP-1366', 'timeFrame': 'up to 24 hours post-dose on Day 5', 'description': 'Cmax,ss of JP-1366'}, {'measure': '[Part 3] AUCτ,ss of JP-1366', 'timeFrame': 'up to 24 hours post-dose on Day 5', 'description': 'AUCτ,ss of JP-1366'}, {'measure': '[Part 3] Cmax,ss of Atorvastatin', 'timeFrame': 'up to 24 hours post-dose on Day 5', 'description': 'Cmax,ss of Atorvastatin'}, {'measure': '[Part 3] AUCτ,ss of Atorvastatin', 'timeFrame': 'up to 24 hours post-dose on Day 5', 'description': 'AUCτ,ss of Atorvastatin'}, {'measure': '[Part 4] Emax of Anti-Factor Xa activity', 'timeFrame': 'up to 48 hours post-dose on Day 5', 'description': 'Emax of Anti-Factor Xa activity'}, {'measure': '[Part 4] AUEC0-12 of Anti-Factor Xa activity', 'timeFrame': 'up to 48 hours post-dose on Day 5', 'description': 'AUEC0-12 of Anti-Factor Xa activity'}, {'measure': '[Part 4] Cmax,ss of JP-1366', 'timeFrame': 'up to 24 hours post-dose on Day 5', 'description': 'Cmax,ss of JP-1366'}, {'measure': '[Part 4] AUCτ,ss of JP-1366', 'timeFrame': 'up to 24 hours post-dose on Day 5', 'description': 'AUCτ,ss of JP-1366'}, {'measure': '[Part 4] Cmax,ss of Apixaban', 'timeFrame': 'up to 12 hours post-dose on Day 5', 'description': 'Cmax,ss of Apixaban'}, {'measure': '[Part 4] AUCτ,ss of Apixaban', 'timeFrame': 'up to 12 hours post-dose on Day 5', 'description': 'AUCτ,ss of Apixaban'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Drug Drug Interaction (DDI)']}, 'descriptionModule': {'briefSummary': 'to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '19 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy subject aged ≥ 19 years to \\< 65 years at the time of screening\n* Subjects who weigh ≥ 50 kg (or ≥ 45 kg in the case of females) with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2\n* Subjects who have voluntarily decided to participate after fully understanding the clinical trial based on the detailed explanation given, and have provided written informed consent before the screening procedure.\n\nExclusion Criteria:\n\n* Subject who has a clinically significant history of disease in the liver, kidneys, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hematopoietic and oncological system, or cardiovascular system.\n* The Subject who has a clinically significant bleeding or a history of congenital or acquired bleeding disorders such as hemophilia\n* Subject who has a history of gastrointestinal disorders (e.g., Crohn's disease, ulcerative disease, etc.) or surgery (excluding appendectomy, hernia repair, endoscopic polypectomy, or hemorrhoidectomy, fissure, or fistula surgery) that may affect the absorption of the investigational product.\n* The subject who has a hereditary disorder (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption etc.).\n* Screening laboratory test showing any of the following abnormal laboratory results\n* Subjects who are judged unsuitable to participate in the study in the opinion of the investigator"}, 'identificationModule': {'nctId': 'NCT07265466', 'briefTitle': 'to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban', 'organization': {'class': 'INDUSTRY', 'fullName': 'Onconic Therapeutics Inc.'}, 'officialTitle': 'A Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban in Healthy Volunteers.', 'orgStudyIdInfo': {'id': 'JP-1366-106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1', 'description': 'JP-1366 and clopidogrel', 'interventionNames': ['Drug: JP-1366 and clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'description': 'JP-1366 and aspirin', 'interventionNames': ['Drug: JP-1366 and aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3', 'description': 'JP-1366 and atorvastatin', 'interventionNames': ['Drug: JP-1366 and atorvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Part 4', 'description': 'JP-1366 and apixaban', 'interventionNames': ['Drug: JP-1366 and apixaban']}], 'interventions': [{'name': 'JP-1366 and clopidogrel', 'type': 'DRUG', 'description': 'A randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design', 'armGroupLabels': ['Part 1']}, {'name': 'JP-1366 and aspirin', 'type': 'DRUG', 'description': 'An open-label, multiple-dosing, fixed sequence, 3-period design', 'armGroupLabels': ['Part 2']}, {'name': 'JP-1366 and atorvastatin', 'type': 'DRUG', 'description': 'An open-label, multiple-dosing, fixed sequence, 3-period design Period 1: Atorvastatin', 'armGroupLabels': ['Part 3']}, {'name': 'JP-1366 and apixaban', 'type': 'DRUG', 'description': 'An open-label, multiple-dosing, fixed sequence, 3-period design', 'armGroupLabels': ['Part 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13496', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'MD, PhD Shin', 'role': 'CONTACT', 'email': 'wonsu89@chamc.co.kr', 'phone': '+82-31-780-5346'}], 'facility': 'Cha University Bundang Medical Center', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Onconic Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}