A Phase I, Randomized, Subject And Investigator Blind, Sponsor Open, Multiple Escalating Dose Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14
研究概览
简要总结
This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of ascending doses administered once daily for 14 days in healthy volunteers.
详细描述
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
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
- 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 of non-child bearing potential 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
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- •History of seizures or of a condition with risk of seizures
- •Pregnant or nursing females, and females of child bearing potential
研究组 & 干预措施
PF-04958242
干预措施: PF-04958242 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14
时间窗: Day 14-Day 18
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1
时间窗: Day 1-Day 2
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4
时间窗: Day 4
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7
时间窗: Day 7
Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14
时间窗: Day 14-Day 15
次要结局
- Digit Symbol Substitution Test(Day 14)
- Drug Effect Questionaire Liking scale(Day 14)
- Columbia Suicide Severity Rating Scale(Day 0-Day 14)