to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban
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.
Onconic Therapeutics Inc.
96 participants
Nov 17, 2025
INTERVENTIONAL
Conditions
Summary
to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban
Eligibility
Inclusion Criteria3
- Healthy subject aged ≥ 19 years to < 65 years at the time of screening
- 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
- 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.
Exclusion Criteria6
- 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.
- The Subject who has a clinically significant bleeding or a history of congenital or acquired bleeding disorders such as hemophilia
- 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.
- The subject who has a hereditary disorder (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption etc.).
- Screening laboratory test showing any of the following abnormal laboratory results
- Subjects who are judged unsuitable to participate in the study in the opinion of the investigator
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Interventions
A randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design
An open-label, multiple-dosing, fixed sequence, 3-period design
An open-label, multiple-dosing, fixed sequence, 3-period design Period 1: Atorvastatin
An open-label, multiple-dosing, fixed sequence, 3-period design
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07265466