Drug Drug Interaction (DDI)Phase 1NCT07265466
to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban
A Phase 1 study testing JP-1366 and clopidogrel, JP-1366 and aspirin and JP-1366 and atorvastatin in people with Drug Drug Interaction (DDI), run by Onconic Therapeutics Inc. at 1 site in South Korea.
Trial summary
to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction (DDI)
- What is being tested?
- JP-1366 and clopidogrel, JP-1366 and aspirin and JP-1366 and atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Nov 2025to 30 Mar 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subject aged ≥ 19 years to < 65 years at the time of screening
- Subjects who weigh ≥ 50 kg (or ≥ 45 kg in the case of females) with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
- Subjects who have voluntarily decided to participate after fully understanding the clinical trial based on the detailed explanation given, and have provided written informed consent before the screening procedure.
Who cannot join
- Subject who has a clinically significant history of disease in the liver, kidneys, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hematopoietic and oncological system, or cardiovascular system.
- The Subject who has a clinically significant bleeding or a history of congenital or acquired bleeding disorders such as hemophilia
- Subject who has a history of gastrointestinal disorders (e.g., Crohn's disease, ulcerative disease, etc.) or surgery (excluding appendectomy, hernia repair, endoscopic polypectomy, or hemorrhoidectomy, fissure, or fistula surgery) that may affect the absorption of the investigational product.
- The subject who has a hereditary disorder (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption etc.).
- Screening laboratory test showing any of the following abnormal laboratory results
- Subjects who are judged unsuitable to participate in the study in the opinion of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Cha University Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496
MD, PhD Shin, +82-31-780-5346, wonsu89@chamc.co.kr
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban in Healthy Volunteers.
to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban
- Conditions
- Drug Drug Interaction (DDI)
- Being tested
- JP-1366 and clopidogrel, JP-1366 and aspirin, JP-1366 and atorvastatin, JP-1366 and apixaban
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JP-1366 and clopidogrelDrug
A randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design
JP-1366 and aspirinDrug
An open-label, multiple-dosing, fixed sequence, 3-period design
JP-1366 and atorvastatinDrug
An open-label, multiple-dosing, fixed sequence, 3-period design Period 1: Atorvastatin
JP-1366 and apixabanDrug
An open-label, multiple-dosing, fixed sequence, 3-period design
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | JP-1366 and clopidogrel Receives: Drug: JP-1366 and clopidogrel |
| Part 2 | Experimental | JP-1366 and aspirin Receives: Drug: JP-1366 and aspirin |
| Part 3 | Experimental | JP-1366 and atorvastatin Receives: Drug: JP-1366 and atorvastatin |
| Part 4 | Experimental | JP-1366 and apixaban Receives: Drug: JP-1366 and apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Part 1] Change in P2Y12 Reaction Unit (PRU) from baseline on day 8
Change in P2Y12 Reaction Unit (PRU)
Measured: baseline on day 8
[Part 2] Emax of arachidonic acid-induced platelet aggregation
Emax of arachidonic acid-induced platelet aggregation
Measured: up to 48 hours post-dose on Day 1
[Part 2] AUEC0-24 of arachidonic acid-induced platelet aggregation
AUEC0-24 of arachidonic acid-induced platelet aggregation
Measured: up to 48 hours post-dose on Day 1
[Part 2] Cmax,ss of JP-1366
Cmax,ss of JP-1366
Measured: up to 24 hours post-dose on Day 5
[Part 2] AUCτ,ss of JP-1366
AUCτ,ss of JP-1366
Measured: up to 24 hours post-dose on Day 5
[Part 2] Cmax of Aspirin
Cmax of Aspirin
Measured: up to 48 hours post-dose on Day 1
[Part 2] AUClast of Aspirin
AUClast of Aspirin
Measured: up to 48 hours post-dose on Day 1
[Part 3] Cmax,ss of JP-1366
Cmax,ss of JP-1366
Measured: up to 24 hours post-dose on Day 5
[Part 3] AUCτ,ss of JP-1366
AUCτ,ss of JP-1366
Measured: up to 24 hours post-dose on Day 5
[Part 3] Cmax,ss of Atorvastatin
Cmax,ss of Atorvastatin
Measured: up to 24 hours post-dose on Day 5
[Part 3] AUCτ,ss of Atorvastatin
AUCτ,ss of Atorvastatin
Measured: up to 24 hours post-dose on Day 5
[Part 4] Emax of Anti-Factor Xa activity
Emax of Anti-Factor Xa activity
Measured: up to 48 hours post-dose on Day 5
[Part 4] AUEC0-12 of Anti-Factor Xa activity
AUEC0-12 of Anti-Factor Xa activity
Measured: up to 48 hours post-dose on Day 5
[Part 4] Cmax,ss of JP-1366
Cmax,ss of JP-1366
Measured: up to 24 hours post-dose on Day 5
[Part 4] AUCτ,ss of JP-1366
AUCτ,ss of JP-1366
Measured: up to 24 hours post-dose on Day 5
[Part 4] Cmax,ss of Apixaban
Cmax,ss of Apixaban
Measured: up to 12 hours post-dose on Day 5
[Part 4] AUCτ,ss of Apixaban
AUCτ,ss of Apixaban
Measured: up to 12 hours post-dose on Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start17 Nov 2025
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug Interaction (DDI)Studies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onconic Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265466
- Sponsor's protocol ID
- JP-1366-106
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT07265466
- Acronym / sponsor ID
- JP-1366-106
- Conditions
- Drug Drug Interaction (DDI)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Onconic Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 4 Dec 2025 (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 Safety and the Pharmacokinetic and Pharmacodynamic Interactions between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: JP-1366 and clopidogrelJP-1366 and clopidogrel |
| Part 2 | Experimental | Drug: JP-1366 and aspirinJP-1366 and aspirin |
| Part 3 | Experimental | Drug: JP-1366 and atorvastatinJP-1366 and atorvastatin |
| Part 4 | Experimental | Drug: JP-1366 and apixabanJP-1366 and apixaban |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subject aged ≥ 19 years to < 65 years at the time of screening
- Subjects who weigh ≥ 50 kg (or ≥ 45 kg in the case of females) with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
- Subjects who have voluntarily decided to participate after fully understanding the clinical trial based on the detailed explanation given, and have provided written informed consent before the screening procedure.
Key exclusion criteria (6 listed)
- Subject who has a clinically significant history of disease in the liver, kidneys, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hematopoietic and oncological system, or cardiovascular system.
- The Subject who has a clinically significant bleeding or a history of congenital or acquired bleeding disorders such as hemophilia
- Subject who has a history of gastrointestinal disorders (e.g., Crohn's disease, ulcerative disease, etc.) or surgery (excluding appendectomy, hernia repair, endoscopic polypectomy, or hemorrhoidectomy, fissure, or fistula surgery) that may affect the absorption of the investigational product.
- The subject who has a hereditary disorder (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption etc.).
- Screening laboratory test showing any of the following abnormal laboratory results
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 and clopidogrelA randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design | Drug | Part 1 |
| JP-1366 and aspirinAn open-label, multiple-dosing, fixed sequence, 3-period design | Drug | Part 2 |
| JP-1366 and atorvastatinAn open-label, multiple-dosing, fixed sequence, 3-period design Period 1: Atorvastatin | Drug | Part 3 |
| JP-1366 and apixabanAn open-label, multiple-dosing, fixed sequence, 3-period design | Drug | Part 4 |
Primary outcome
[Part 1] Change in P2Y12 Reaction Unit (PRU) from baseline on day 8
Time frame: baseline on day 8
Change in P2Y12 Reaction Unit (PRU)
[Part 2] Emax of arachidonic acid-induced platelet aggregation
Time frame: up to 48 hours post-dose on Day 1
Emax of arachidonic acid-induced platelet aggregation
[Part 2] AUEC0-24 of arachidonic acid-induced platelet aggregation
Time frame: up to 48 hours post-dose on Day 1
AUEC0-24 of arachidonic acid-induced platelet aggregation
[Part 2] Cmax,ss of JP-1366
Time frame: up to 24 hours post-dose on Day 5
Cmax,ss of JP-1366
[Part 2] AUCτ,ss of JP-1366
Time frame: up to 24 hours post-dose on Day 5
AUCτ,ss of JP-1366
[Part 2] Cmax of Aspirin
Time frame: up to 48 hours post-dose on Day 1
Cmax of Aspirin
[Part 2] AUClast of Aspirin
Time frame: up to 48 hours post-dose on Day 1
AUClast of Aspirin
[Part 3] Cmax,ss of JP-1366
Time frame: up to 24 hours post-dose on Day 5
Cmax,ss of JP-1366
[Part 3] AUCτ,ss of JP-1366
Time frame: up to 24 hours post-dose on Day 5
AUCτ,ss of JP-1366
[Part 3] Cmax,ss of Atorvastatin
Time frame: up to 24 hours post-dose on Day 5
Cmax,ss of Atorvastatin
[Part 3] AUCτ,ss of Atorvastatin
Time frame: up to 24 hours post-dose on Day 5
AUCτ,ss of Atorvastatin
[Part 4] Emax of Anti-Factor Xa activity
Time frame: up to 48 hours post-dose on Day 5
Emax of Anti-Factor Xa activity
[Part 4] AUEC0-12 of Anti-Factor Xa activity
Time frame: up to 48 hours post-dose on Day 5
AUEC0-12 of Anti-Factor Xa activity
[Part 4] Cmax,ss of JP-1366
Time frame: up to 24 hours post-dose on Day 5
Cmax,ss of JP-1366
[Part 4] AUCτ,ss of JP-1366
Time frame: up to 24 hours post-dose on Day 5
AUCτ,ss of JP-1366
[Part 4] Cmax,ss of Apixaban
Time frame: up to 12 hours post-dose on Day 5
Cmax,ss of Apixaban
[Part 4] AUCτ,ss of Apixaban
Time frame: up to 12 hours post-dose on Day 5
AUCτ,ss of Apixaban
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- 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.
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 and clopidogrel, JP-1366 and aspirin and JP-1366 and atorvastatin in people with Drug Drug Interaction (DDI), 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 3 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
[Part 1] Change in P2Y12 Reaction Unit (PRU) from baseline on day 8 (time frame: baseline on day 8). The study lists 17 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 4 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.