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NCT Number: NCT07265466

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

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

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Key information

Conditions

Drug Drug Interaction (DDI)

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cha University Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location status: Recruiting

Location contact

MD, PhD Shin

CONTACT

[email protected]

+82-31-780-5346

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JP-1366 and clopidogrel

Drug

A randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design

JP-1366 and aspirin

Drug

An open-label, multiple-dosing, fixed sequence, 3-period design

JP-1366 and atorvastatin

Drug

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

JP-1366 and apixaban

Drug

An open-label, multiple-dosing, fixed sequence, 3-period design

Primary outcomes

  1. [Part 1] Change in P2Y12 Reaction Unit (PRU) from baseline on day 8

    Time frame: baseline on day 8

    Change in P2Y12 Reaction Unit (PRU)

  2. [Part 2] Emax of arachidonic acid-induced platelet aggregation

    Time frame: up to 48 hours post-dose on Day 1

    Emax of arachidonic acid-induced platelet aggregation

  3. [Part 2] AUEC0-24 of arachidonic acid-induced platelet aggregation

    Time frame: up to 48 hours post-dose on Day 1

    AUEC0-24 of arachidonic acid-induced platelet aggregation

  4. [Part 2] Cmax,ss of JP-1366

    Time frame: up to 24 hours post-dose on Day 5

    Cmax,ss of JP-1366

  5. [Part 2] AUCτ,ss of JP-1366

    Time frame: up to 24 hours post-dose on Day 5

    AUCτ,ss of JP-1366

  6. [Part 2] Cmax of Aspirin

    Time frame: up to 48 hours post-dose on Day 1

    Cmax of Aspirin

  7. [Part 2] AUClast of Aspirin

    Time frame: up to 48 hours post-dose on Day 1

    AUClast of Aspirin

  8. [Part 3] Cmax,ss of JP-1366

    Time frame: up to 24 hours post-dose on Day 5

    Cmax,ss of JP-1366

  9. [Part 3] AUCτ,ss of JP-1366

    Time frame: up to 24 hours post-dose on Day 5

    AUCτ,ss of JP-1366

  10. [Part 3] Cmax,ss of Atorvastatin

    Time frame: up to 24 hours post-dose on Day 5

    Cmax,ss of Atorvastatin

  11. [Part 3] AUCτ,ss of Atorvastatin

    Time frame: up to 24 hours post-dose on Day 5

    AUCτ,ss of Atorvastatin

  12. [Part 4] Emax of Anti-Factor Xa activity

    Time frame: up to 48 hours post-dose on Day 5

    Emax of Anti-Factor Xa activity

  13. [Part 4] AUEC0-12 of Anti-Factor Xa activity

    Time frame: up to 48 hours post-dose on Day 5

    AUEC0-12 of Anti-Factor Xa activity

  14. [Part 4] Cmax,ss of JP-1366

    Time frame: up to 24 hours post-dose on Day 5

    Cmax,ss of JP-1366

  15. [Part 4] AUCτ,ss of JP-1366

    Time frame: up to 24 hours post-dose on Day 5

    AUCτ,ss of JP-1366

  16. [Part 4] Cmax,ss of Apixaban

    Time frame: up to 12 hours post-dose on Day 5

    Cmax,ss of Apixaban

  17. [Part 4] AUCτ,ss of Apixaban

    Time frame: up to 12 hours post-dose on Day 5

    AUCτ,ss of Apixaban

Sponsors and collaborators

Lead sponsor

Onconic Therapeutics Inc.

Industry

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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