A Double Blind, Placebo-Controlled, Randomized, Dose Escalation Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 (Filibuvir) Following Single Oral Administrations Of PF-00868554 (Filibuvir) Under Fasting Conditions In Japanese Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety; ECGs/vital signs
研究概览
简要总结
A single dose of PF-00868554 (filibuvir) will be safety and tolerable in Japanese healthy volunteers. The pharmacokinetics in Japanese will be consistent to that available in Western population.
详细描述
Investigation of safety, tolerability and pharmacokinetics of single oral administration of PF-00868554 (filibuvir) in healthy adult Japanese volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects between the ages of 20 and 55 years.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.
排除标准
- •A positive result for Hepatitis B surface antigen (HbsAg) or anti-hepatitis C virus serology, and HIV antigen/antibody.
- •Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
- •Pregnant or nursing females; females of childbearing potential.
研究组 & 干预措施
Cohort 1
PF-00868554 (filibuvir) 100 mg or placebo
干预措施: Active (Drug)
Cohort 1
PF-00868554 (filibuvir) 100 mg or placebo
干预措施: Placebo (Drug)
Cohort 2
PF-00868554 (filibuvir) 300 mg or placebo
干预措施: Active (Drug)
Cohort 2
PF-00868554 (filibuvir) 300 mg or placebo
干预措施: Placebo (Drug)
Cohort 3
PF-00868554 (filibuvir) 500 mg or placebo
干预措施: Active (Drug)
Cohort 3
PF-00868554 (filibuvir) 500 mg or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety; ECGs/vital signs
时间窗: Screening to Follow-up (Day 5)
Safety; laboratory tests
时间窗: Screening to Follow-up (Day 5)
Safety; physical examination/adverse event monitoring
时间窗: Screening to Follow-up (Day 5)
次要结局
- Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations(Day 1 to Day 3)
- Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations(Day 1 to Day 3)