Healthy Volunteers
Conditions
Keywords
JPI-547, Food Effect, Ethnicity, Pharmacokinetics
Brief 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.
Detailed description
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.
Interventions
DRUGJPI-547
JPI-547 is administered orally as a single dose per administration.
Sponsors
Onconic Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
19 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed