A Phase 1, Placebo-Controlled, Crossover Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 After First-Time Administration Of Single Ascending Doses To Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single doses will include neurological assessment, vital signs and adverse event reporting during inpatient stay.
研究概览
简要总结
The purpose of this first in human (FIH) study is to investigate the safety, tolerability, pharmacokinetics ( how the body handles the drug) and pharmacodynamics (how the drug affects the body) of PF-04455242-01 in healthy adult volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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 of non-childbearing potential between the ages of 18 and 55 years.
- •Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (>110 lbs).
- •Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
排除标准
- •Evidence or history of clinically significant medical condition or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening).
- •Use of tobacco- or nicotine-containing products within 3 months of screening or a positive urine or blood cotinine at screening.
- •A positive urine drug screen. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men.
研究组 & 干预措施
Treatment
2 cohorts will recieve single rising doses of PF-04455242 or placebo in a cross-over fashion.
干预措施: PF-04455242 (Drug)
Placebo
2 cohorts will receive single rising doses of PF-04455242 or placebo in a cross-over fashion.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of single doses will include neurological assessment, vital signs and adverse event reporting during inpatient stay.
时间窗: Daily
Physical exam
时间窗: Screening, End of Trial (EOT), and Follow Up (F/U)
Clinical safety laboratory results
时间窗: Screening, Day 0 (D0), D2, F/U
12-lead ECGs
时间窗: Screening, D1, D2, F/U
Maximum plasma concentration (Cmax), time to reach maximum concentration (Tmax), area under the concentration-time curve (AUC) and terminal half-life (t1/2) .
时间窗: 0 hr (predose) then 0.5-1 hr for the next 12 hrs postdose on D1, then 24, 36, 48, & 72 hrs postdose
次要结局
- Likert and Drug Effect Questionnaire (DEQ) questionnaires(0 hr (predose) then 1, 2, 3, 4, 6 ,8, & 12 hrs (postdose) on D1, then 24 hrs (postdose) on D2)