Anti-Ulcer AgentsPhase 1NCT05181124
Compare Pharmacokinetics and Safety of JP-1366 Between Korean and Caucasian
A Phase 1 study testing coadministration of JP-1366 and aceclofenac, coadministration of JP-1366 and meloxicam and coadministration of JP-1366 and naproxen in people with Anti-Ulcer Agents, run by Onconic Therapeutics Inc. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anti-Ulcer Agents
- What is being tested?
- coadministration of JP-1366 and aceclofenac, coadministration of JP-1366 and meloxicam and coadministration of JP-1366 and naproxen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Mar 2021to 23 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Anti-Ulcer Agents
- Being tested
- coadministration of JP-1366 and aceclofenac, coadministration of JP-1366 and meloxicam, coadministration of JP-1366 and naproxen, single-dosing of JP-1366 in Korean and Caucasian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
single-dosing of JP-1366 in Korean and CaucasianDrug
An open-label, single-dosing, parallel design
| Study group | Role | What they receive |
|---|---|---|
| JP-1366 and aceclofenac | Experimental | Not described Receives: Drug: coadministration of JP-1366 and aceclofenac |
| JP-1366 and meloxicam | Experimental | Not described Receives: Drug: coadministration of JP-1366 and meloxicam |
| JP-1366 and naproxen | Experimental | Not described Receives: Drug: coadministration of JP-1366 and naproxen |
| JP-1366 | Experimental | Not described Receives: Drug: single-dosing of JP-1366 in Korean and Caucasian |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1
- Cmax,ss of JP-1366
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start5 Mar 2021
- Primary completion15 Mar 2021
- Study completion23 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Ulcer AgentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onconic Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181124
- Sponsor's protocol ID
- JP-1366-103
- Status last verified
- Jan 2022
- First submitted
- 23 Nov 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05181124
- Acronym / sponsor ID
- JP-1366-103
- Conditions
- Anti-Ulcer Agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Onconic Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 23 Mar 2021 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coadministration of JP-1366 and aceclofenacAn open-label, multiple-dosing, fixed sequence, 3-period design | Drug | JP-1366 and aceclofenac |
| coadministration of JP-1366 and meloxicamAn open-label, multiple-dosing, fixed sequence, 3-period design | Drug | JP-1366 and meloxicam |
| coadministration of JP-1366 and naproxenAn open-label, multiple-dosing, fixed sequence, 3-period design | Drug | JP-1366 and naproxen |
| single-dosing of JP-1366 in Korean and CaucasianAn open-label, single-dosing, parallel design | Drug | JP-1366 |
Primary outcome
Part 1
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
- Cmax,ss of JP-1366
Part 1
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
- AUCτ,ss of JP-1366
Part 1
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
- Cmax aceclofenac
Part 1
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
- AUCτ aceclofenac
Part 1
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)
- Cmax,ss of JP-1366
Part 1
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)
- AUCτ,ss of JP-1366
Part 1
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)
- AUCτ of aceclofenac
Part 1
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)
- Cmax of aceclofenac
Part 1
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)
- Cmax,ss of JP-1366
Part 1
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)
- AUCτ,ss of JP-1366
Part 1
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)
- Cmax of aceclofenac
Part 1
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)
- AUCτ of aceclofenac
Part 2
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)
- Cmax,ss of JP-1366, meloxicam
Part 2
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)
- AUCτ,ss of JP-1366, meloxicam
Part 2
Time frame: 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
Part 2
Time frame: 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
Part 2
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)
- Cmax,ss of JP-1366, meloxicam
Part 2
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)
- AUCτ,ss of JP-1366, meloxicam
Part 3
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)
- Cmax,ss of JP-1366, naproxen
Part 3
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)
- AUCτ,ss of JP-1366, naproxen
Part 3
Time frame: 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
Part 3
Time frame: 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
Part 3
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)
- Cmax,ss of JP-1366, naproxen
Part 3
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)
- AUCτ,ss of JP-1366, naproxen
Part 4
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)
- Cmax of JP-1366 in Korean and Caucasian
Part 4
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)
- AUClast of JP-1366 in Korean and Caucasian
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing coadministration of JP-1366 and aceclofenac, coadministration of JP-1366 and meloxicam and coadministration of JP-1366 and naproxen in people with Anti-Ulcer Agents, run by Onconic Therapeutics Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 (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). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.