A Phase 1 Clinical Study of E6130 - Clinical Pharmacology Study in Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as a measure of safety and tolerability
研究概览
简要总结
The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of E6130 in Japanese healthy adult male participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 44 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participants must meet all of the following criteria to be included in this study.
- •Japanese or Caucasian healthy adult males aged ≥20 and <45 years at the time of informed consent who are non-smokers or able to stop smoking from at least 4 weeks before study drug administration until the post-treatment examination
- •Has voluntarily consented, in writing, to participate in this study
- •Has been thoroughly briefed on the conditions for participation in the study, and are willing and able to comply with the conditions
排除标准
- •Participants who meet any of the following criteria will be excluded from this study.
- •History of surgical treatment may affect the pharmacokinetics of the study drug at screening
- •Suspected to have clinically abnormal symptoms or impairment of organ function requiring treatment on the basis of history and complications at screening, and physical findings, vital signs, electrocardiogram findings, or laboratory values at screening or baseline
- •History of drug allergy at screening
- •Judged by the investigator or sub investigator to be inappropriate for participation in this study
研究组 & 干预措施
Cohort A1
Japanese participants will receive a single oral dose of E6130 on Day 1 and Day 7 administered in the specified order (fasted/fed or fed/fasted) to evaluate the food effect.
干预措施: E6130 (Drug)
Cohort B1
Caucasian participants will receive a single oral dose of either E6130 or placebo on Day 1.
干预措施: E6130 (Drug)
Cohort B1
Caucasian participants will receive a single oral dose of either E6130 or placebo on Day 1.
干预措施: Placebo (Drug)
Cohorts A2-A4
Japanese participants will receive multiple oral doses of E6130 or placebo on Days 1 to 5, administered in a randomized, dose-ascending manner.
干预措施: E6130 (Drug)
Cohorts A2-A4
Japanese participants will receive multiple oral doses of E6130 or placebo on Days 1 to 5, administered in a randomized, dose-ascending manner.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as a measure of safety and tolerability
时间窗: Days 1 to 14 (Cohort A1); Days 1 to 12 (Cohorts A2 to A4); Days 1 to 8 (Cohort B1)
次要结局
- Area under the serum concentration-time curve from zero time to 24 hours (AUC[0-24h]) of E6130(Days 1 to 7 (Cohorts A2 to A4))
- Maximum observed serum concentration (Cmax) of E6130(Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1))
- Maximum observed serum concentration at steady state (Css, max) of E6130(Days 1 to 7 (Cohorts A2 to A4))
- Time to Cmax (tmax) of E6130(Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1))
- Time to Cmax at steady state (tss, max) of E6130(Days 1 to 7 (Cohorts A2 to A4))
- Area under the serum concentration-time curve from zero time to the time of last quantifiable concentration (AUC[0-t]) of E6130(Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1))
- Area under the serum concentration-time curve from zero time extrapolated to infinite time (AUC[0-inf]) of E6130(Days 1 to 4 and Days 7 to 10 (Cohort A1); Days 1 to 4 (Cohort B1))
- Terminal elimination phase half-life (t1/2) of E6130(Days 1 to 7 (Cohorts A2 to A4))