Food and Ethnicity Effects on Pharmacokinetics and Safety of JPI-547 in Healthy Male Participants

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.

1. 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.
2. 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.

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