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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-64
SponsorOnconic Therapeutics Inc.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.).

Trial design

Treatments tested in this trial

  • JP-1366 and clopidogrel
  • JP-1366 and aspirin
  • JP-1366 and atorvastatin
  • JP-1366 and apixaban

Treatment groups

96 Participants
are divided into 4 treatment groups

Sponsors and collaborators