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

NCT07570186 | Not Yet Recruiting Phase 1

• 1 other identifier: JPI-547-104
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

JPI-547; Food Effect; Ethnicity; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Maximum Plasma Concentration (Cmax) of JPI-547

  Cmax is defined as the maximum observed plasma concentration of JPI-547 after a single oral administration.

  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.

• 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.

  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.

• 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.

  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.

Study Arms (2)

Korean/Caucasian Participants: JPI-547 Fed/Fasted Crossover

EXPERIMENTAL

Healthy Korean and Caucasian male participants receive a single oral dose of JPI-547 in each treatment period under fed and fasted conditions in a crossover design.

Drug: JPI-547

Chinese Participants: JPI-547 Fasted

EXPERIMENTAL

Healthy Chinese male participants receive a single oral dose of JPI-547 under fasting conditions.

Drug: JPI-547

Interventions

JPI-547 DRUG

JPI-547 is administered orally as a single dose per administration.

Chinese Participants: JPI-547 Fasted; Korean/Caucasian Participants: JPI-547 Fed/Fasted Crossover

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Onconic Therapeutics Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

KR (1)