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

NCT07265466 | Recruiting Phase 1

• 1 other identifier: JP-1366-106
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Drug Interaction (DDI)

Outcome Measures

Primary Outcomes (17)

• [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

Study Arms (4)

Part 1

EXPERIMENTAL

JP-1366 and clopidogrel

Drug: JP-1366 and clopidogrel

Part 2

EXPERIMENTAL

JP-1366 and aspirin

Drug: JP-1366 and aspirin

Part 3

EXPERIMENTAL

JP-1366 and atorvastatin

Drug: JP-1366 and atorvastatin

Part 4

EXPERIMENTAL

JP-1366 and apixaban

Drug: JP-1366 and apixaban

Interventions

JP-1366 and atorvastatin DRUG

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

Part 3

JP-1366 and apixaban DRUG

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

Part 4

JP-1366 and clopidogrel DRUG

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

Part 1

JP-1366 and aspirin DRUG

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

Part 2

Eligibility Criteria

• Age: 19 Years - 64 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Onconic Therapeutics Inc.: lead

Study Sites (1)

Cha University Bundang Medical Center

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

RECRUITING

MeSH Terms

Interventions

Clopidogrel; Aspirin; Atorvastatin; apixaban

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (open label)
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 4, 2025
• Study Start: November 17, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)