A Double Blind, 3rd Party Open, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index
研究概览
简要总结
The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).
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 btween the ages of 18-55 years
- •Body Mass Index (BMI) of 15.5 to 30.5 and a total body weight greater than 50kg (110 lbs).
排除标准
- •Evidence or history of clinically signifcant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- •A positive urine drug screen.
- •History of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening
- •Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
- •Pregnant or nursing females; females of childbearing potentioal who are unwilling or unable to use an acceptable method on contraception.
研究组 & 干预措施
Cohort 1
干预措施: PF-04531083 or Placebo (Drug)
Cohort 2
干预措施: PF-04531083 or Placebo (Drug)
Cohort 3
干预措施: PF-04531083 or Placebo (Drug)
Cohort 4
干预措施: PF-04531083 or Placebo (Drug)
结局指标
主要结局
Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index
时间窗: days 1-15
Safety of subjects following multiple dosing of PF-04531083 (adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood and urine safety tests)
时间窗: days 1-15
次要结局
- pharmacokinetics of alternative formulations(days 1-15)