RecruitingPhase 1NCT07265466

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.


Sponsor

Onconic Therapeutics Inc.

Enrollment

96 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban


Eligibility

Min Age: 19 YearsMax Age: 64 Years

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

DRUGJP-1366 and clopidogrel

A randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design

DRUGJP-1366 and aspirin

An open-label, multiple-dosing, fixed sequence, 3-period design

DRUGJP-1366 and atorvastatin

An open-label, multiple-dosing, fixed sequence, 3-period design Period 1: Atorvastatin

DRUGJP-1366 and apixaban

An open-label, multiple-dosing, fixed sequence, 3-period design


Locations(1)

Cha University Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

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NCT07265466


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