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

• Sponsor: Onconic Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05181124
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 4
• Actual Duration (Days): 18
• Patients Per Site Per Month: 148.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anti-Ulcer Agents	Drug: coadministration of JP-1366 and aceclofenac; Drug: coadministration of JP-1366 and meloxicam; Drug: coadministration of JP-1366 and naproxen; Drug: single-dosing of JP-1366 in Korean and Caucasian	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 5, 2021
• Actual Primary Completion Date: Mar 15, 2021
• Actual Study Completion Date: Mar 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: JP-1366 and aceclofenac	Drug: coadministration of JP-1366 and aceclofenac; An open-label, multiple-dosing, fixed sequence, 3-period design
Experimental: JP-1366 and meloxicam	Drug: coadministration of JP-1366 and meloxicam; An open-label, multiple-dosing, fixed sequence, 3-period design
Experimental: JP-1366 and naproxen	Drug: coadministration of JP-1366 and naproxen; An open-label, multiple-dosing, fixed sequence, 3-period design
Experimental: JP-1366	Drug: single-dosing of JP-1366 in Korean and Caucasian; An open-label, single-dosing, parallel design

Outcome Measures

Primary Outcome Measures

1. Part 1 [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]

   - Cmax,ss of JP-1366

2. Part 1 [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]

   - AUCτ,ss of JP-1366

3. Part 1 [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]

   - Cmax aceclofenac

4. Part 1 [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]

   - AUCτ aceclofenac

5. Part 1 [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)]

   - Cmax,ss of JP-1366

6. Part 1 [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)]

   - AUCτ,ss of JP-1366

7. Part 1 [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)]

   - AUCτ of aceclofenac

8. Part 1 [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)]

   - Cmax of aceclofenac

9. Part 1 [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)]

   - Cmax,ss of JP-1366

10. Part 1 [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)]

    - AUCτ,ss of JP-1366

11. Part 1 [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)]

    - Cmax of aceclofenac

12. Part 1 [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)]

    - AUCτ of aceclofenac

13. Part 2 [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)]

    - Cmax,ss of JP-1366, meloxicam

14. Part 2 [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)]

    - AUCτ,ss of JP-1366, meloxicam

15. Part 2 [Single dosing of Meloxicam: 19day 0hour (before IP administration), 1, 2, 3, 4, 5, 6, 8, 12, 24hour (20day 0hour)]

    - Cmax,ss of JP-1366, meloxicam

16. Part 2 [Single dosing of Meloxicam: 19day 0hour (before IP administration), 1, 2, 3, 4, 5, 6, 8, 12, 24hour (20day 0hour)]

    - AUCτ,ss of JP-1366, meloxicam

17. Part 2 [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)]

    - Cmax,ss of JP-1366, meloxicam

18. Part 2 [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)]

    - AUCτ,ss of JP-1366, meloxicam

19. Part 3 [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)]

    - Cmax,ss of JP-1366, naproxen

20. Part 3 [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)]

    - AUCτ,ss of JP-1366, naproxen

21. Part 3 [Single dosing of naproxen: 19day 0hour (before IP administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour]

    - Cmax,ss of JP-1366, naproxen

22. Part 3 [Single dosing of naproxen: 19day 0hour (before IP administration), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hour]

    - AUCτ,ss of JP-1366, naproxen

23. Part 3 [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)]

    - Cmax,ss of JP-1366, naproxen

24. Part 3 [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)]

    - AUCτ,ss of JP-1366, naproxen

25. Part 4 [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)]

    - Cmax of JP-1366 in Korean and Caucasian

26. Part 4 [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)]

    - AUClast of JP-1366 in Korean and Caucasian

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cha University Bundang Medical Center	Gyeonggi-do		Korea, Republic of

Sponsors and Collaborators

• Onconic Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Onconic Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT05181124
• Other Study ID Numbers: JP-1366-103
• First Posted: Jan 6, 2022
• Last Update Posted: Jun 30, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Naproxen; Meloxicam; Aceclofenac

Study Results

No Results Posted as of Jun 30, 2022