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

Anti-Ulcer Agents Clinical Trial

Official title:

Clinical Trial To Evaluate Pharmacokinetic Interactions and Safety Between JP-1366 and Aceclofenac, Meloxicam, and Naproxen in Korean Healthy Volunteers and Compare Pharmacokinetics and Safety of JP-1366 Between Korean and Caucasian

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05181124
• Other study ID #: JP-1366-103
• Status: Completed
• Phase: Phase 1
• Start date: March 5, 2021
• Est. completion date: March 23, 2021

Study information

• Verified date: January 2022
• Source: Onconic Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 23, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anti-Ulcer Agents

Intervention

Drug:
• coadministration of JP-1366 and aceclofenac
An open-label, multiple-dosing, fixed sequence, 3-period design
• coadministration of JP-1366 and meloxicam
An open-label, multiple-dosing, fixed sequence, 3-period design
• coadministration of JP-1366 and naproxen
An open-label, multiple-dosing, fixed sequence, 3-period design
• single-dosing of JP-1366 in Korean and Caucasian
An open-label, single-dosing, parallel design

Locations

Country	Name	City	State
Korea, Republic of	Cha University Bundang Medical Center	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Onconic Therapeutics Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1	- Cmax,ss of JP-1366	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
Primary	Part 1	- AUCt,ss of JP-1366	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
Primary	Part 1	- Cmax aceclofenac	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
Primary	Part 1	- AUCt aceclofenac	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
Primary	Part 1	- Cmax,ss of JP-1366	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)
Primary	Part 1	- AUCt,ss of JP-1366	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)
Primary	Part 1	- AUCt of aceclofenac	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)
Primary	Part 1	- Cmax of aceclofenac	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)
Primary	Part 1	- Cmax,ss of JP-1366	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)
Primary	Part 1	- AUCt,ss of JP-1366	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)
Primary	Part 1	- Cmax of aceclofenac	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)
Primary	Part 1	- AUCt of aceclofenac	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)
Primary	Part 2	- Cmax,ss of JP-1366, meloxicam	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)
Primary	Part 2	- AUCt,ss of JP-1366, meloxicam	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)
Primary	Part 2	- Cmax,ss of JP-1366, meloxicam	Single dosing of Meloxicam: 19day 0hour (before IP administration), 1, 2, 3, 4, 5, 6, 8, 12, 24hour (20day 0hour)
Primary	Part 2	- AUCt,ss of JP-1366, meloxicam	Single dosing of Meloxicam: 19day 0hour (before IP administration), 1, 2, 3, 4, 5, 6, 8, 12, 24hour (20day 0hour)
Primary	Part 2	- Cmax,ss of JP-1366, meloxicam	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)
Primary	Part 2	- AUCt,ss of JP-1366, meloxicam	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)
Primary	Part 3	- Cmax,ss of JP-1366, naproxen	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)
Primary	Part 3	- AUCt,ss of JP-1366, naproxen	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)
Primary	Part 3	- Cmax,ss of JP-1366, naproxen	Single dosing of naproxen: 19day 0hour (before IP administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour
Primary	Part 3	- AUCt,ss of JP-1366, naproxen	Single dosing of naproxen: 19day 0hour (before IP administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour
Primary	Part 3	- Cmax,ss of JP-1366, naproxen	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)
Primary	Part 3	- AUCt,ss of JP-1366, naproxen	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)
Primary	Part 4	- Cmax of JP-1366 in Korean and Caucasian	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)
Primary	Part 4	- AUClast of JP-1366 in Korean and Caucasian	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)