About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
JPI-547
DrugJPI-547 is administered orally as a single dose per administration.
Treatment groups
Trial outcomes
Primary outcomes
Maximum Plasma Concentration (Cmax) of JPI-547
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
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
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: