Набор скоро начнётся NCT07570186

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

Фаза I С лечением Healthy Volunteers

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: JPI-547.
Кому может быть актуально: Состояния в реестре: Healthy Volunteers. Базовые параметры: 19 лет — 50 лет · Мужчины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: South Korea
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

Maximum Plasma Concentration (Cmax) of JPI-547 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

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