A Phase 1, Randomized, Double Blind (Sponsor-Open), Placebo Controlled, Dose Escalation, Multiple Dose Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Plasma PF-00868554 concentrations
研究概览
简要总结
Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple oral administrations of PF-00868554 in Japanese healthy adult volunteers.
详细描述
Study A8121018 was prematurely discontinued due to FDA instructions stating that Study A8121018 could not be performed under US IND 78,910, which was provided by the meeting on August 13, 2009. And then the termination was decided by Pfizer on September 8, 2009 prior to subject dosing with PF-00868554. There were no safety concerns regarding the study in the decision to terminate the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 female Japanese subjects between the ages of 18 and 55 years.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
排除标准
- •Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
- •Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs.
- •Pregnant or nursing females; females of childbearing potential.
研究组 & 干预措施
Cohort 1
PF-00868554 100 mg or placebo
干预措施: PF-00868554 or Placebo (Drug)
Cohort 2
PF-00868554 300 mg or placebo
干预措施: PF-00868554 or Placebo (Drug)
Cohort 3
PF-00868554 600 mg or placebo
干预措施: PF-00868554 or Placebo (Drug)
结局指标
主要结局
Plasma PF-00868554 concentrations
时间窗: Day 1-Day 17
Urine PF-00868554 concentrations
时间窗: Day 1 and Day 14
Adverse event monitoring and Physical examination
时间窗: Day 0-Day 17
ECGs and vital signs (Blood pressure and Pulse rate)
时间窗: Day 1-Day 17
Clinical safety laboratory tests
时间窗: Day 0, Day 7, and Day 17
次要结局
未报告次要终点