Safety and drug interactions of JP-1366 with clopidogrel, aspirin, atorvastatin, and apixaban

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional drug–drug interaction study in healthy adult volunteers to characterize pharmacokinetic and pharmacodynamic interactions between JP-1366 and four commonly used medications (clopidogrel, aspirin, atorvastatin, and apixaban). Participants will receive JP-1366 alone and in combination with each partner drug while investigators collect blood samples for drug levels and biomarkers of drug effect and clotting. Safety monitoring will include vital signs, laboratory tests, and recording of adverse events throughout the study. The goal is to define any changes in exposure or effect that would inform safe co-prescribing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Cha University Bundang Medical Center
  Seongnam-si, Gyeonggi-do, South Korea Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.