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

Onconic Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Drug Drug Interaction (DDI)

Treatments: Drug: JP-1366 and aspirin; Drug: JP-1366 and apixaban; Drug: JP-1366 and clopidogrel; Drug: JP-1366 and atorvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT07265466

JP-1366-106

Details and patient eligibility

About

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

Enrollment: 96 estimated patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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96 participants in 4 patient groups

Part 1

Experimental group

Description:

JP-1366 and clopidogrel

Treatment:

Drug: JP-1366 and clopidogrel

Part 2

Experimental group

Description:

JP-1366 and aspirin

Treatment:

Drug: JP-1366 and aspirin

Part 3

Experimental group

Description:

JP-1366 and atorvastatin

Treatment:

Drug: JP-1366 and atorvastatin

Part 4

Experimental group

Description:

JP-1366 and apixaban

Treatment:

Drug: JP-1366 and apixaban