Clinical Trials in South Korea / NCT07570186
Starting soon
Phase 1
Food and Ethnicity Effects on Pharmacokinetics and Safety of JPI-547 in Healthy Male Participants
NCT07570186 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Healthy Volunteers
Investigational drug(s) / intervention(s)
JPI-547: JPI-547 is administered orally as a single dose per administration.
Study 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.
Eligibility
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
Primary outcome measure(s)
- Maximum Plasma Concentration (Cmax) of JPI-547 — 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 — 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
More Onconic Therapeutics Inc. trials in South Korea
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07570186 on ClinicalTrials.gov ↗ ← All trials in South Korea