HealthyPhase 1NCT05712681
Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers
A Phase 1 study testing JP-1366 20mg tablet in people with Healthy, run by Onconic Therapeutics Inc. at 1 site in South Korea.
Trial summary
To Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral single dose of JP-1366 tablet in Healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JP-1366 20mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Mar 2023to 18 May 2023
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A healthy adult aged between 19 and 45 years old
- BMI between 18.0kg/m2 and 27.0kg/m2 at the time of screening
Who cannot join
- The subject who has clinically significant disease with liver, endocrine system, immune system, nervous system, kidney, cardiovascular disease, mental disorder, the blood of tumor disease, respiratory system or with history of the disease.
- The subject who has a history of gastrointestinal disorders(e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or history of gastrointestinal surgery
- The subject who has an allergic disease(excluding mild allergic rhinitis that does not require administration) or has a history of clinically significant hypersensitivity or adverse reactions to clinical trial drugs or drugs containing the same or other drugs (aspirin, NSAIDs, antibiotics, etc.).
- The subject who has other clinically significant diseases or history
- The subject who has a history of drug abuse
- The subject who cannot withstand the insertion and maintenance of pH catheters
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers
To Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral single dose of JP-1366 tablet in Healthy volunteers
- Conditions
- Healthy
- Being tested
- JP-1366 20mg tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JP-1366 20mg tabletDrug
T : JP-1366 20mg tablet after the meal
JP-1366 20mg tabletDrug
R : JP-1366 20mg tablet under fasting condition
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | T → Washout period(7-14days) → R Receives: Drug: JP-1366 20mg tablet |
| Sequence 2 | Experimental | R → Washout period(7-14days) → T Receives: Drug: JP-1366 20mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of JP-1366
Measured: Pre-dose(0 hour) and up to 34 hours in each period
AUClast of JP-1366
Measured: Pre-dose(0 hour) and up to 34 hours in each period
Secondary outcomes (1)
Gastric pH
Measured: Pre-dose(0 hour) up to 24 hours after Investigational product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start29 Mar 2023
- Primary completion4 May 2023
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT05712681
- Sponsor's protocol ID
- JP-1366-105
- Status last verified
- Jan 2023
- First submitted
- 13 Jan 2023
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee H, Yoon SK, Jung SM, Lee MH, Lee SH, Kim EN, Kim J, Cha H, Bae KS, Lim HS. Effect of Food on the Pharmacokinetics, Pharmacodynamics, and Safety of Zastaprazan, a Potassium-Competitive Acid Blocker, in Healthy Participants. Clin Transl Sci. 2026 Nov;19(11):e70757. doi: 10.1111/cts.70757.
PubMed 42963322
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral Single Dose of JP-1366 Tablet in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05712681
- Acronym / sponsor ID
- JP-1366-105
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Onconic Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 3 Feb 2023 (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 Food-Effects on Pharmacokinetics and Pharmacodynamics of Oral single dose of JP-1366 tablet in Healthy volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: JP-1366 20mg tabletT → Washout period(7-14days) → R |
| Sequence 2 | Experimental | Drug: JP-1366 20mg tabletR → Washout period(7-14days) → T |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- A healthy adult aged between 19 and 45 years old
- BMI between 18.0kg/m2 and 27.0kg/m2 at the time of screening
Key exclusion criteria (6 listed)
- The subject who has clinically significant disease with liver, endocrine system, immune system, nervous system, kidney, cardiovascular disease, mental disorder, the blood of tumor disease, respiratory system or with history of the disease.
- The subject who has a history of gastrointestinal disorders(e.g., gastroesophageal reflux disease, gastrospasm, gastritis, gastrointestinal ulcers, Crohn's disease, etc.) or history of gastrointestinal surgery
- The subject who has an allergic disease(excluding mild allergic rhinitis that does not require administration) or has a history of clinically significant hypersensitivity or adverse reactions to clinical trial drugs or drugs containing the same or other drugs (aspirin, NSAIDs, antibiotics, etc.).
- The subject who has other clinically significant diseases or history
- The subject who has a history of drug abuse
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 |
|---|---|---|
| JP-1366 20mg tabletT : JP-1366 20mg tablet after the meal | Drug | Sequence 1, Sequence 2 |
| JP-1366 20mg tabletR : JP-1366 20mg tablet under fasting condition | Drug | Sequence 1, Sequence 2 |
Primary outcome
Cmax of JP-1366
Time frame: Pre-dose(0 hour) and up to 34 hours in each period
AUClast of JP-1366
Time frame: Pre-dose(0 hour) and up to 34 hours in each period
1 secondary outcome
Gastric pH
Time frame: Pre-dose(0 hour) up to 24 hours after Investigational product administration
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 26 Aug 2024.
- Derived from this study: PubMed 42963322Lee H, Yoon SK, Jung SM, Lee MH, Lee SH, Kim EN, Kim J, Cha H, Bae KS, Lim HS. Effect of Food on the Pharmacokinetics, Pharmacodynamics, and Safety of Zastaprazan, a Potassium-Competitive Acid Blocker, in Healthy Participants. Clin Transl Sci. 2026 Nov;19(11):e70757. doi: 10.1111/cts.70757.
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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 JP-1366 20mg tablet in people with Healthy, 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 2 inclusion and 6 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 26 Aug 2024. 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?
Cmax of JP-1366 (time frame: Pre-dose(0 hour) and up to 34 hours in each period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05712681, which also lists 1 linked publication.
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 26 Aug 2024.