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

Onconic Therapeutics Inc.88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anti-Ulcer Agents

Interventions

coadministration of JP-1366 and aceclofenacDRUG

An open-label, multiple-dosing, fixed sequence, 3-period design

coadministration of JP-1366 and meloxicamDRUG

An open-label, multiple-dosing, fixed sequence, 3-period design

coadministration of JP-1366 and naproxenDRUG

An open-label, multiple-dosing, fixed sequence, 3-period design

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Cha University Bundang Medical Center

Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Part 1

\- Cmax,ss of JP-1366

Time frame: Single dosing of aceclofenac: 1day 0hour (before IP administration), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12hour

Part 1

\- AUCτ,ss of JP-1366

Time frame: Single dosing of aceclofenac: 1day 0hour (before IP administration), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12hour

Part 1

\- Cmax aceclofenac

Time frame: Single dosing of aceclofenac: 1day 0hour (before IP administration), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12hour

Part 1

\- AUCτ aceclofenac

Time frame: Single dosing of aceclofenac: 1day 0hour (before IP administration), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12hour

Part 1

\- Cmax,ss of JP-1366

Time frame: Single dosing of JP-1366: 4day 0hour, 6day 0hour, 7day 0hour, 8day 0hour (before IP administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hour (9day 0hour)

Part 1

\- AUCτ,ss of JP-1366

Time frame: Single dosing of JP-1366: 4day 0hour, 6day 0hour, 7day 0hour, 8day 0hour (before IP administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hour (9day 0hour)

Part 1

\- AUCτ of aceclofenac

Time frame: Single dosing of JP-1366: 4day 0hour, 6day 0hour, 7day 0hour, 8day 0hour (before IP administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24h (9day 0hour)

Part 1

\- Cmax of aceclofenac

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

An open-label, single-dosing, parallel design

Time frame: Single dosing of JP-1366: 4day 0hour, 6day 0hour, 7day 0hour, 8day 0hour (before IP administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hour (9day 0hour)

Part 1

\- Cmax,ss of JP-1366

Time frame: Coadministration of JP-1366 and aceclofenac: 9day 0hour (before IP administration), 0.25, 0.5, 0.75† , 1, 1.5, 2, 2.5‡ , 3, 4, 6, 8, 10, 12, 24hour (10day 0hour)

Part 1

\- AUCτ,ss of JP-1366

Time frame: Coadministration of JP-1366 and aceclofenac: 9day 0hour (before IP administration), 0.25, 0.5, 0.75† , 1, 1.5, 2, 2.5‡ , 3, 4, 6, 8, 10, 12, 24hour (10day 0hour)

Part 1

\- Cmax of aceclofenac

Time frame: Coadministration of JP-1366 and aceclofenac: 9day 0hour (before IP administration), 0.25, 0.5, 0.75† , 1, 1.5, 2, 2.5‡ , 3, 4, 6, 8, 10, 12, 24hour (10day 0hour)

Part 1

\- AUCτ of aceclofenac

Time frame: Coadministration of JP-1366 and aceclofenac: 9day 0hour (before IP administration), 0.25, 0.5, 0.75† , 1, 1.5, 2, 2.5‡ , 3, 4, 6, 8, 10, 12, 24hour (10day 0hour)

Part 2

\- Cmax,ss of JP-1366, meloxicam

Time frame: Single dosing of JP-1366: 1day 0hour, 3day 0hour, 4day 0hour, 5day 0hour (before IP administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24hour (6day 0hour), 15day 0hour (before IP administration)

Part 2

\- AUCτ,ss of JP-1366, meloxicam

Part 2

\- Cmax,ss of JP-1366, meloxicam

Time frame: Single dosing of Meloxicam: 19day 0hour (before IP administration), 1, 2, 3, 4, 5, 6, 8, 12, 24hour (20day 0hour)

Part 2

\- AUCτ,ss of JP-1366, meloxicam

Time frame: Single dosing of Meloxicam: 19day 0hour (before IP administration), 1, 2, 3, 4, 5, 6, 8, 12, 24hour (20day 0hour)

Part 2

\- Cmax,ss of JP-1366, meloxicam

Time frame: Coadministration of JP-1366 and meloxicam: 22day 0hour† , 24day 0hour† , 25day 0hour† , 26day 0hour (before IP administration), 0.25† , 0.5† , 0.75† , 1, 1.5† , 2, 3, 4, 5‡ , 6, 8, 10† , 12, 24hour (27day 0hour)

Part 2

\- AUCτ,ss of JP-1366, meloxicam

Part 3

\- Cmax,ss of JP-1366, naproxen

Part 3

\- AUCτ,ss of JP-1366, naproxen

Part 3

\- Cmax,ss of JP-1366, naproxen

Time frame: Single dosing of naproxen: 19day 0hour (before IP administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour

Part 3

\- AUCτ,ss of JP-1366, naproxen

Time frame: Single dosing of naproxen: 19day 0hour (before IP administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour

Part 3

\- Cmax,ss of JP-1366, naproxen

Time frame: Coadministration of JP-1366 and naproxen: 22day 0hour† , 24day 0hour† , 25day 0hour† , 26day 0hour (before IP administration), 0.25† , 0.5, 0.75† , 1, 1.5, 2, 2.5‡ , 3, 4, 5, 6, 8, 10† , 12, 24hour (27day 0hour)

Part 3

\- AUCτ,ss of JP-1366, naproxen

Part 4

\- Cmax of JP-1366 in Korean and Caucasian

Time frame: 1day 0hour (before IP administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 (2day 0hour), 48hour (3day 0hour)

Part 4

\- AUClast of JP-1366 in Korean and Caucasian

Time frame: 1day 0hour (before IP administration), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 (2day 0hour), 48hour (3day 0hour)