Compare Pharmacokinetics and Safety of JP-1366 Between Korean and Caucasian

Onconic Therapeutics

Status and phase: Completed; Phase 1

Conditions: Anti-Ulcer Agents

Treatments: Drug: coadministration of JP-1366 and naproxen; Drug: single-dosing of JP-1366 in Korean and Caucasian; Drug: coadministration of JP-1366 and aceclofenac; Drug: coadministration of JP-1366 and meloxicam

Study type: Interventional

Funder types: Industry

Identifiers

NCT05181124

JP-1366-103

Details and patient eligibility

About

To evaluate the effect of coadministration of aceclofenac, meloxicam and naproxen on pharmacokinetic interactions and safety of JP-1366 in healthy Korean subjects and to compare the pharmacokinetic nature and safety of JP-1366 between healthy Korean and Caucasian.

Enrollment: 88 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject who has fully informed about this study and understand co mpletely, decide to participate voluntarily and agree with the writte n consent before screening test.
• A healthy volunteer in the age of upper 19 at the time of the scree ning test.
• Subject whose BMI was 18.0 or more and 30.0 or less and whose b ody weight was 50kg or more if in male, and 45kg or more if in fe male at the same time.
• Caucasian in Part 4 who has medical interview and documents(passport, birth certificate) or signatured conformation by the subject.

Exclusion criteria

• The Subject who has clinically significant diseases with liver, kidney, nervous system, digestive system, immune system, respiratory system, and endocrine system, musculoskeletal system or the blood or tumor disease, cardiovascular disease (including orthostatic hypotension), mental disorder or with history of the disease.
• The subject who has a history of gastrointestinal disorders (gastrointestinal ulcers, gastritis, gastric ulcer, gastroesophageal reflux disease, Crohn's disease, etc.) or history of gastrointestinal surgery that may affect the safety and PK/PD Evaluation of the investigational product (Except for simple cecal surgery and hernia surgery)
• The subject who has a hereditary disorder (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption etc.).
• The subject who has a history of an active peptic ulcer or bleeding.
• Screening laboratory test showing any of the following abnormal laboratory results: ALT, AST, Total bilirubin > 2.0 x ULN - e-GFR < 60 mL/min/1.73m2 (CKD-EPI formula) - Positive result for Serological test (HBsAg, HCV Ab, HIV Ab, Syphilis regain test)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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88 participants in 4 patient groups

JP-1366 and aceclofenac

Experimental group

Treatment:

Drug: coadministration of JP-1366 and aceclofenac

JP-1366 and meloxicam

Experimental group

Treatment:

Drug: coadministration of JP-1366 and meloxicam

JP-1366 and naproxen

Experimental group

Treatment:

Drug: coadministration of JP-1366 and naproxen

JP-1366

Experimental group

Treatment:

Drug: single-dosing of JP-1366 in Korean and Caucasian