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

ConditionDrug Drug Interaction (DDI)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19-64
SponsorOnconic Therapeutics Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.).

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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

Treatment groups

96 Participants
are divided into 4 treatment groups
Group A: Part 1Experimental treatment 1 intervention
Group B: Part 2Experimental treatment 1 intervention
Group C: Part 3Experimental treatment 1 intervention
Group D: Part 4Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Change in P2Y12 Reaction Unit (PRU)

Time frame
baseline on day 8
2

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

Emax of arachidonic acid-induced platelet aggregation

Time frame
up to 48 hours post-dose on Day 1
3

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

AUEC0-24 of arachidonic acid-induced platelet aggregation

Time frame
up to 48 hours post-dose on Day 1
4

[Part 2] Cmax,ss of JP-1366

Cmax,ss of JP-1366

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Onconic Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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