to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and 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.

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

Study Overview

• Status: Recruiting
• Conditions: Drug Drug Interaction (DDI)
• Intervention / Treatment: Drug: JP-1366 and clopidogrel; Drug: JP-1366 and aspirin; Drug: JP-1366 and atorvastatin; Drug: JP-1366 and apixaban

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13496
      • Recruiting
      • CHA University Bundang Medical Center
      • Contact: MD, PhD Shin; Phone Number: +82-31-780-5346; Email: wonsu89@chamc.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; JP-1366 and clopidogrel	Drug: JP-1366 and clopidogrel; A randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design
Experimental: Part 2; JP-1366 and aspirin	Drug: JP-1366 and aspirin; An open-label, multiple-dosing, fixed sequence, 3-period design
Experimental: Part 3; JP-1366 and atorvastatin	Drug: JP-1366 and atorvastatin; An open-label, multiple-dosing, fixed sequence, 3-period design Period 1: Atorvastatin
Experimental: Part 4; JP-1366 and apixaban	Drug: JP-1366 and apixaban; An open-label, multiple-dosing, fixed sequence, 3-period design

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Onconic Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fatty Acids; Lipids; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Pyrroles; Heptanoic Acids; Thiophenes; Salicylates; Hydroxybenzoates; Ticlopidine; Thienopyridines; Atorvastatin; Clopidogrel; Aspirin; apixaban
• Other Study ID Numbers: JP-1366-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No