Food and Ethnicity Effects on Pharmacokinetics and Safety of JPI-547 in Healthy Male Participants (NCT07570186) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Food and Ethnicity Effects on Pharmacokinetics and Safety of JPI-547 in Healthy Male Participants
South Korea36 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
19 Years – 50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Plasma Concentration (Cmax) of JPI-547
Timeframe: 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.
2
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of JPI-547
Timeframe: 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.
3
Number of Participants With Abnormalities in Safety and Tolerability Assessments
Timeframe: 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.