Drug Drug Interaction (DDI)
Conditions
Brief summary
to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban
Interventions
DRUGJP-1366 and apixaban
An open-label, multiple-dosing, fixed sequence, 3-period design
DRUGJP-1366 and aspirin
An open-label, multiple-dosing, fixed sequence, 3-period design
DRUGJP-1366 and atorvastatin
An open-label, multiple-dosing, fixed sequence, 3-period design Period 1: Atorvastatin
DRUGJP-1366 and clopidogrel
A randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design
Sponsors
Onconic Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Masking description
None (open label)
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [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 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 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 |
Countries
South Korea
Outcome results
None listed