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
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of JPI-547
研究概览
简要总结
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.
详细描述
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: JPI-547 (Drug)
Chinese Participants: JPI-547 Fasted
Healthy Chinese male participants receive a single oral dose of JPI-547 under fasting conditions.
干预措施: JPI-547 (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of JPI-547
时间窗: 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.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of JPI-547
时间窗: 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.
Number of Participants With Abnormalities in Safety and Tolerability Assessments
时间窗: 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.
次要结局
未报告次要终点