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

April 29, 2026 updated by: Onconic Therapeutics Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Korean/Caucasian Participants: JPI-547 Fed/Fasted Crossover
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
JPI-547 is administered orally as a single dose per administration.
Experimental: Chinese Participants: JPI-547 Fasted
Healthy Chinese male participants receive a single oral dose of JPI-547 under fasting conditions.
Drug: JPI-547
JPI-547 is administered orally as a single dose per administration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration (Cmax) of JPI-547
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.
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
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Onconic Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JPI-547-104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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