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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age19-50
SponsorOnconic Therapeutics Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • JPI-547

    Drug

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

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Korean/Caucasian Participants: JPI-547 Fed/Fasted CrossoverExperimental treatment 1 intervention
Group B: Chinese Participants: JPI-547 FastedExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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.

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.
3

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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