Safety and drug interactions of JP-1366 with 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.
This trial will test whether JP-1366 changes how clopidogrel, aspirin, atorvastatin, or apixaban are processed or affect blood clotting in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 19 Years to 64 Years |
| Sex | All |
| Sponsor | Onconic Therapeutics Inc. Industry-sponsored |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT07265466 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Healthy adults aged 19 to under 65 years with BMI 18–30 kg/m2 and meeting the study weight criteria who can give informed consent are ideal candidates.
Not a fit: People with clinically significant liver, kidney, cardiovascular, bleeding, gastrointestinal, neuropsychiatric, hematologic, oncologic, or other major medical conditions would not benefit because they are excluded from this healthy-volunteer study.
Why it matters
Potential benefit: If successful, the results could help prescribers avoid harmful interactions and guide safe co‑use of JP-1366 with common cardiovascular and lipid‑lowering medications.
How similar studies have performed: Drug–drug interaction studies using healthy volunteers and PK/PD sampling are a standard and well-established approach and have successfully defined interaction risks for many small-molecule drugs, though JP-1366 itself is a novel agent.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seongnam-si, Gyeonggi-do
- Cha University Bundang Medical Center — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.