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

Phase 1Not Yet RecruitingNCT07570186

Onconic Therapeutics Inc.36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

JPI-547DRUG

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

Eligibility

Sex: MALEMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

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.

Time frame: 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.

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.

Time frame: 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.

Data from ClinicalTrials.gov

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