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Clinical Trials in South Korea / NCT07265466
Recruiting Phase 1

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

NCT07265466 · tracked via the Priya Life Science South Korea tracker
Sponsor
Onconic Therapeutics Inc
Phase
Phase 1
Started
2025-11-17
Last updated
2025-12-04

Condition(s) studied

Drug Drug Interaction (DDI)

Investigational drug(s) / intervention(s)

JP-1366 and clopidogrelJP-1366 and aspirinJP-1366 and atorvastatinJP-1366 and apixaban

JP-1366 and clopidogrel: A randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design

JP-1366 and aspirin: An open-label, multiple-dosing, fixed sequence, 3-period design

JP-1366 and atorvastatin: An open-label, multiple-dosing, fixed sequence, 3-period design Period 1: Atorvastatin

JP-1366 and apixaban: An open-label, multiple-dosing, fixed sequence, 3-period design

Study summary

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

Eligibility

Sex
ALL
Min age
19 Years
Max age
64 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • [Part 1] Change in P2Y12 Reaction Unit (PRU) from baseline on day 8 — baseline on day 8
    Change in P2Y12 Reaction Unit (PRU)
  • [Part 2] Emax of arachidonic acid-induced platelet aggregation — up to 48 hours post-dose on Day 1
    Emax of arachidonic acid-induced platelet aggregation
  • [Part 2] AUEC0-24 of arachidonic acid-induced platelet aggregation — up to 48 hours post-dose on Day 1
    AUEC0-24 of arachidonic acid-induced platelet aggregation
  • [Part 2] Cmax,ss of JP-1366 — up to 24 hours post-dose on Day 5
    Cmax,ss of JP-1366
  • [Part 2] AUCτ,ss of JP-1366 — up to 24 hours post-dose on Day 5
    AUCτ,ss of JP-1366
  • [Part 2] Cmax of Aspirin — up to 48 hours post-dose on Day 1
    Cmax of Aspirin
  • [Part 2] AUClast of Aspirin — up to 48 hours post-dose on Day 1
    AUClast of Aspirin
  • [Part 3] Cmax,ss of JP-1366 — up to 24 hours post-dose on Day 5
    Cmax,ss of JP-1366
  • [Part 3] AUCτ,ss of JP-1366 — up to 24 hours post-dose on Day 5
    AUCτ,ss of JP-1366
  • [Part 3] Cmax,ss of Atorvastatin — up to 24 hours post-dose on Day 5
    Cmax,ss of Atorvastatin
  • [Part 3] AUCτ,ss of Atorvastatin — up to 24 hours post-dose on Day 5
    AUCτ,ss of Atorvastatin
  • [Part 4] Emax of Anti-Factor Xa activity — up to 48 hours post-dose on Day 5
    Emax of Anti-Factor Xa activity
  • [Part 4] AUEC0-12 of Anti-Factor Xa activity — up to 48 hours post-dose on Day 5
    AUEC0-12 of Anti-Factor Xa activity
  • [Part 4] Cmax,ss of JP-1366 — up to 24 hours post-dose on Day 5
    Cmax,ss of JP-1366
  • [Part 4] AUCτ,ss of JP-1366 — up to 24 hours post-dose on Day 5
    AUCτ,ss of JP-1366
  • [Part 4] Cmax,ss of Apixaban — up to 12 hours post-dose on Day 5
    Cmax,ss of Apixaban
  • [Part 4] AUCτ,ss of Apixaban — up to 12 hours post-dose on Day 5
    AUCτ,ss of Apixaban

Trial sites (1)

FacilityCityRegionStatus
Cha University Bundang Medical Center Seongnam-si Gyeonggi-do Recruiting

More Onconic Therapeutics Inc. trials in South Korea

To Evaluate the Efficacy and Safety of JPI-547 in Combination With Bevacizumab as Maintenance Therapy in Relapsed Ovarian Cancer Starting soon
Food and Ethnicity Effects on Pharmacokinetics and Safety of JPI-547 in Healthy Male Participants Starting soon
To Evaluate the Safety and Tolerability of Study Drug as a Third-line and Beyond Therapy for Recurrent or Metastatic Gastric Cancer Starting soon
Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers Recruiting
Study to Assess the Safety, Tolerability of JPI-547 in Combination With Modified FOLFIRINOX or Gemcitabine-nab-paclitaxel in Patients With Locally Advanced and Metastatic Pancreatic Cancer Recruiting

Other trials for the same condition

Drug-Drug Interaction of Rifampicin and Cyclosporine on Methotrexate Pharmacokinetics in Healthy Subjects Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07265466 on ClinicalTrials.gov ↗ ← All trials in South Korea