NCT05181124

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2021

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
Last Updated

June 30, 2022

Status Verified

January 1, 2022

Enrollment Period

10 days

First QC Date

November 23, 2021

Last Update Submit

June 28, 2022

Conditions

Anti-Ulcer Agents

Outcome Measures

Primary Outcomes (26)

  • 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

  • Part 1

    \- AUCτ,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

  • 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

  • Part 1

    \- AUCτ 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

  • 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)

  • Part 1

    \- AUCτ,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)

  • Part 1

    \- AUCτ 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)

  • 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)

  • 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)

  • Part 1

    \- AUCτ,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)

  • 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)

  • Part 1

    \- AUCτ 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)

  • 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)

  • Part 2

    \- AUCτ,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)

  • 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)

  • Part 2

    \- AUCτ,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)

  • 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)

  • Part 2

    \- AUCτ,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)

  • 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)

  • Part 3

    \- AUCτ,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)

  • 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

  • Part 3

    \- AUCτ,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

  • 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)

  • Part 3

    \- AUCτ,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)

  • 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)

  • 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)

Study Arms (4)

JP-1366 and aceclofenac

EXPERIMENTAL
Drug: coadministration of JP-1366 and aceclofenac

JP-1366 and meloxicam

EXPERIMENTAL
Drug: coadministration of JP-1366 and meloxicam

JP-1366 and naproxen

EXPERIMENTAL
Drug: coadministration of JP-1366 and naproxen

JP-1366

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

Interventions

coadministration of JP-1366 and aceclofenacDRUG

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

JP-1366 and aceclofenac
coadministration of JP-1366 and meloxicamDRUG

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

JP-1366 and meloxicam
coadministration of JP-1366 and naproxenDRUG

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

JP-1366 and naproxen
single-dosing of JP-1366 in Korean and CaucasianDRUG

An open-label, single-dosing, parallel design

JP-1366

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cha University Bundang Medical Center

Gyeonggi-do, South Korea

Location

MeSH Terms

Interventions

aceclofenacMeloxicamNaproxen

Intervention Hierarchy (Ancestors)

ThiazinesSulfur CompoundsOrganic ChemicalsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNaphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2021

First Posted

January 6, 2022

Study Start

March 5, 2021

Primary Completion

March 15, 2021

Study Completion

March 23, 2021

Last Updated

June 30, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)