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Recruiting NCT07265466

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

Phase I Interventional Drug Drug Interaction (DDI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JP-1366 and clopidogrel, JP-1366 and aspirin, JP-1366 and atorvastatin, JP-1366 and apixaban.
Who it may be relevant to
Registry conditions: Drug Drug Interaction (DDI). Basic parameters: 19 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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

Interventions

  • Drug JP-1366 and clopidogrel
    A randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design
  • Drug JP-1366 and aspirin
    An open-label, multiple-dosing, fixed sequence, 3-period design
  • Drug JP-1366 and atorvastatin
    An open-label, multiple-dosing, fixed sequence, 3-period design Period 1: Atorvastatin
  • Drug JP-1366 and apixaban
    An open-label, multiple-dosing, fixed sequence, 3-period design

Primary outcome measures

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

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Cha University Bundang Medical Center — Seongnam-si

Identifiers

NCT: NCT07265466 · JP-1366-106

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗