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

Официальное название

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.

Обзор

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

Вмешательства

• Препарат JP-1366 and clopidogrel
  A randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design
• Препарат JP-1366 and aspirin
  An open-label, multiple-dosing, fixed sequence, 3-period design
• Препарат JP-1366 and atorvastatin
  An open-label, multiple-dosing, fixed sequence, 3-period design Period 1: Atorvastatin
• Препарат JP-1366 and apixaban
  An open-label, multiple-dosing, fixed sequence, 3-period design

Первичные конечные точки

• [Part 1] Change in P2Y12 Reaction Unit (PRU) from baseline on day 8 [Срок оценки: baseline on day 8]
• [Part 2] Emax of arachidonic acid-induced platelet aggregation [Срок оценки: up to 48 hours post-dose on Day 1]
• [Part 2] AUEC0-24 of arachidonic acid-induced platelet aggregation [Срок оценки: up to 48 hours post-dose on Day 1]
• [Part 2] Cmax,ss of JP-1366 [Срок оценки: up to 24 hours post-dose on Day 5]
• [Part 2] AUCτ,ss of JP-1366 [Срок оценки: up to 24 hours post-dose on Day 5]
• [Part 2] Cmax of Aspirin [Срок оценки: up to 48 hours post-dose on Day 1]
• [Part 2] AUClast of Aspirin [Срок оценки: up to 48 hours post-dose on Day 1]
• [Part 3] Cmax,ss of JP-1366 [Срок оценки: up to 24 hours post-dose on Day 5]
• [Part 3] AUCτ,ss of JP-1366 [Срок оценки: up to 24 hours post-dose on Day 5]
• [Part 3] Cmax,ss of Atorvastatin [Срок оценки: up to 24 hours post-dose on Day 5]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Cha University Bundang Medical Center — Seongnam-si

Идентификаторы

NCT: NCT07265466 · JP-1366-106

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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