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Not yet recruiting NCT07570186

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

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JPI-547.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 19 years — 50 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

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

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

Primary outcome measures

  • 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.]
  • 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.]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT07570186 · JPI-547-104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗