An Investigator- And Subjects- Blind Phase 1 Study To Investigate Pharmacokinetics, Safety And Tolerability Of Sitaxentan In Japanese Healthy Subjects Following Single And Multiple Doses And Western Healthy Subjects Following Single Dose
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Adverse events (spontaneous and solicited)
研究概览
简要总结
The purpose of this study is to investigate safety, tolerability and pharmacokinetics of sitaxentan following single and multiple oral administrations of sitaxentan sodium in Japanese healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects between the age of 18 and 55 years, inclusive.
- •Body Mass Index of 17.5 to 33.5 kg/m2, and a total body weight >45 kg. Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.
排除标准
- •Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
研究组 & 干预措施
Japanese Cohort
Single and multiple oral doses of sitaxentan sodium or placebo in 12 healthy subjects.
干预措施: Sitaxentan sodium/Placebo (Drug)
Western Cohort
Single oral dose of sitaxentan sodium in 10 healthy subjects.
干预措施: Sitaxentan sodium/Placebo (Drug)
结局指标
主要结局
Adverse events (spontaneous and solicited)
时间窗: Day 0 to Day 9 of Period 3 for cohort 1, Day 0 to Day 3 of Period 2 for cohort 2
ECGs, Vital signs, Safety laboratory test
时间窗: Screening visit to Day 9 of Period 3 for cohort 1 and Day 3 of Period 2 for cohort 2
Pharmacokinetics (single dose): Cmax, Tmax, AUC, t1/2, CL/F and V/F
时间窗: Day 1 of Periods 1 and 2
Pharmacokinetics (multiple dose): Cmax, Tmax, Ctrough, AUC, t1/2, CL/F, V/F, Rac and Rss
时间窗: Days 1 and 7 of Periods 1 and 3
次要结局
- No secondary outcome(No secondary outcome)