Healthy VolunteersPhase 1NCT07570186
Food and Ethnicity Effects on Pharmacokinetics and Safety of JPI-547 in Healthy Male Participants
A Phase 1 study testing JPI-547 in people with Healthy Volunteers, run by Onconic Therapeutics Inc. at 1 site in South Korea.
Trial summary
This study aims to evaluate the effects of food or ethnicity on the pharmacokinetics and safety/tolerability of JPI-547 after a single oral administration in healthy male Korean, Caucasian, and Chinese participants. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- JPI-547
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2026to Jul 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Korean, Caucasian, or Chinese male participants aged 19 to 50 years at screening
- Body weight between 50.0 and 90.0 kg and BMI between 18.5 and 29.9 kg/m²
- Able to understand the study and provide written informed consent
- Considered suitable for study participation by the investigator based on medical history, physical examination, and clinical laboratory tests
Who cannot join
- Clinically significant medical or surgical history
- Gastrointestinal disease or surgery affecting drug absorption
- Hypersensitivity to PARP inhibitors or other significant drug allergy
- Drug abuse history or positive drug screening
- Clinically significant abnormal vital signs or laboratory results
- Positive viral or serologic screening tests
Show all 12Show fewer
- Recent use of prohibited medications
- Recent participation in another clinical trial
- Recent blood donation or transfusion
- Inability to abstain from smoking, alcohol, caffeine, or grapefruit
- Failure to comply with contraception or sperm donation requirements
- Any condition making the participant unsuitable in the investigator's judgment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-label, Single-dose, Crossover Phase 1 Clinical Trial to Evaluate the Effects of Food or Ethnicity on the Pharmacokinetics and Safety/Tolerability of JPI-547 After a Single Oral Administration in Healthy Male Korean, Caucasian and Chinese Participants
This study aims to evaluate the effects of food or ethnicity on the pharmacokinetics and safety/tolerability of JPI-547 after a single oral administration in healthy male Korean, Caucasian, and Chinese participants.
Read the detailed description
- Cohort 1 is designed to evaluate the effect of food on the pharmacokinetics and safety/tolerability of JPI-547 in healthy Korean and Caucasian participants under fasted and fed conditions.
- Cohort 2 is designed to explore the effect of ethnicity on the pharmacokinetics and safety/tolerability of JPI-547 in healthy Chinese participants after a single oral administration.
- Conditions
- Healthy Volunteers
- Being tested
- JPI-547
- Keywords
- JPI-547, Food Effect, Ethnicity, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JPI-547Drug
JPI-547 is administered orally as a single dose per administration.
| Study group | Role | What they receive |
|---|---|---|
| Korean/Caucasian Participants: JPI-547 Fed/Fasted Crossover | Experimental | Healthy Korean and Caucasian male participants receive a single oral dose of JPI-547 in each treatment period under fed and fasted conditions in a crossover design. Receives: Drug: JPI-547 |
| Chinese Participants: JPI-547 Fasted | Experimental | Healthy Chinese male participants receive a single oral dose of JPI-547 under fasting conditions. Receives: Drug: JPI-547 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of JPI-547
Cmax is defined as the maximum observed plasma concentration of JPI-547 after a single oral administration.
Measured: Pre-dose through 120 hours post-dose after each administration, based on 17 PK samples per administration; assessed up to Day 20 for the Korean/Caucasian fed/fasted crossover arm and up to Day 6 for the Chinese fasted arm.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of JPI-547
AUClast is defined as the area under the plasma concentration-time curve from time zero to the last quantifiable concentration of JPI-547 after a single oral administration.
Measured: Pre-dose through 120 hours post-dose after each administration, based on 17 PK samples per administration; assessed up to Day 20 for the Korean/Caucasian fed/fasted crossover arm and up to Day 6 for the Chinese fasted arm.
Number of Participants With Abnormalities in Safety and Tolerability Assessments
Safety and tolerability will be assessed by monitoring adverse events, including subjective and objective symptoms, physical examinations, vital signs, 12-lead electrocardiograms, and clinical laboratory tests after a single oral administration of JPI-547.
Measured: From the first administration of JPI-547 until the Post-Study Visit; assessed up to Day 32 for the Korean/Caucasian fed/fasted crossover arm and up to Day 18 for the Chinese fasted arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study startMay 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study consists of 2 cohorts. Cohort 1 is a randomized, open-label, crossover study to evaluate the food effect of JPI-547 in healthy Korean and Caucasian male participants. Cohort 2 is an open-label, single-dose study to explore ethnic differences in the pharmacokinetics and safety/tolerability of JPI-547 in healthy Chinese male participants under fasted conditions.
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT07570186
- Sponsor's protocol ID
- JPI-547-104
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, Crossover Phase 1 Clinical Trial to Evaluate the Effects of Food or Ethnicity on the Pharmacokinetics and Safety/Tolerability of JPI-547 After a Single Oral Administration in Healthy Male Korean, Caucasian and Chinese Participants
- ClinicalTrials.gov ID
- NCT07570186
- Acronym / sponsor ID
- JPI-547-104
- Conditions
- Healthy Volunteers
- Keywords
- JPI-547, Food Effect, Ethnicity, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Onconic Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- May 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 6 May 2026 (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.
This study aims to evaluate the effects of food or ethnicity on the pharmacokinetics and safety/tolerability of JPI-547 after a single oral administration in healthy male Korean, Caucasian, and Chinese participants.
Detailed description
- Cohort 1 is designed to evaluate the effect of food on the pharmacokinetics and safety/tolerability of JPI-547 in healthy Korean and Caucasian participants under fasted and fed conditions.
- Cohort 2 is designed to explore the effect of ethnicity on the pharmacokinetics and safety/tolerability of JPI-547 in healthy Chinese participants after a single oral administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study consists of 2 cohorts. Cohort 1 is a randomized, open-label, crossover study to evaluate the food effect of JPI-547 in healthy Korean and Caucasian male participants. Cohort 2 is an open-label, single-dose study to explore ethnic differences in the pharmacokinetics and safety/tolerability of JPI-547 in healthy Chinese male participants under fasted conditions.
| Arm | Type | Receives |
|---|---|---|
| Korean/Caucasian Participants: JPI-547 Fed/Fasted Crossover | Experimental | Drug: JPI-547Healthy Korean and Caucasian male participants receive a single oral dose of JPI-547 in each treatment period under fed and fasted conditions in a crossover design. |
| Chinese Participants: JPI-547 Fasted | Experimental | Drug: JPI-547Healthy Chinese male participants receive a single oral dose of JPI-547 under fasting conditions. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Korean, Caucasian, or Chinese male participants aged 19 to 50 years at screening
- Body weight between 50.0 and 90.0 kg and BMI between 18.5 and 29.9 kg/m²
- Able to understand the study and provide written informed consent
- Considered suitable for study participation by the investigator based on medical history, physical examination, and clinical laboratory tests
Key exclusion criteria (12 listed)
- Clinically significant medical or surgical history
- Gastrointestinal disease or surgery affecting drug absorption
- Hypersensitivity to PARP inhibitors or other significant drug allergy
- Drug abuse history or positive drug screening
- Clinically significant abnormal vital signs or 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 |
|---|---|---|
| JPI-547JPI-547 is administered orally as a single dose per administration. | Drug | Chinese Participants: JPI-547 Fasted, Korean/Caucasian Participants: JPI-547 Fed/Fasted Crossover |
Primary outcome
Maximum Plasma Concentration (Cmax) of JPI-547
Time frame: Pre-dose through 120 hours post-dose after each administration, based on 17 PK samples per administration; assessed up to Day 20 for the Korean/Caucasian fed/fasted crossover arm and up to Day 6 for the Chinese fasted arm.
Cmax is defined as the maximum observed plasma concentration of JPI-547 after a single oral administration.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of JPI-547
Time frame: Pre-dose through 120 hours post-dose after each administration, based on 17 PK samples per administration; assessed up to Day 20 for the Korean/Caucasian fed/fasted crossover arm and up to Day 6 for the Chinese fasted arm.
AUClast is defined as the area under the plasma concentration-time curve from time zero to the last quantifiable concentration of JPI-547 after a single oral administration.
Number of Participants With Abnormalities in Safety and Tolerability Assessments
Time frame: From the first administration of JPI-547 until the Post-Study Visit; assessed up to Day 32 for the Korean/Caucasian fed/fasted crossover arm and up to Day 18 for the Chinese fasted arm.
Safety and tolerability will be assessed by monitoring adverse events, including subjective and objective symptoms, physical examinations, vital signs, 12-lead electrocardiograms, and clinical laboratory tests after a single oral administration of JPI-547.
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 6 May 2026.
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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.
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 JPI-547 in people with Healthy Volunteers, 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 12 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: opening soon, as of the sponsor's last update on 6 May 2026. 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?
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?
Maximum Plasma Concentration (Cmax) of JPI-547 (time frame: Pre-dose through 120 hours post-dose after each administration, based on 17 PK samples per administration; assessed up to Day 20 for the Korean/Caucasian fed/fasted crossover arm and up to Day 6 for the Chinese fasted arm.). The study lists 3 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 6 May 2026.