A Phase 1, Randomized Investigator-And-Subject-Blind, Sponsor Open, Placebo Controlled Two-Part Study To Characterize The Pharmacokinetics And Pharmacodynamics Of Single Doses Of Pf-05297909 In Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Plasma area under the curve last (AUClast) pharmacokinetic parameter
研究概览
简要总结
This study is designed to observe the safety and concentrations of PF-05297909 and proteins in both blood and cerebrospinal fluid after a single dose of PF-05297909 in healthy adults.
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
- •For Healthy adult volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.)
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
研究组 & 干预措施
Dose Escalation
Ascending doses in healthy volunteers
干预措施: PF-05297909 25 mg (Drug)
Dose Escalation
Ascending doses in healthy volunteers
干预措施: PF-05297909 100 mg (Drug)
Dose Escalation
Ascending doses in healthy volunteers
干预措施: PF-05297909 250 mg (Drug)
Dose Escalation
Ascending doses in healthy volunteers
干预措施: PF-05297909 525 mg (Drug)
Part 2: CSF PKPD
Pharmacokinetic and pharmacodynamic cerebrospinal fluid assessment
干预措施: PF-05297909 525 mg (Drug)
结局指标
主要结局
Plasma area under the curve last (AUClast) pharmacokinetic parameter
时间窗: Day 1 to Day 3
Plasma apparent clearance (CL/F) pharmacokinetic parameter
时间窗: Day 0 to Day 3
Clinical potency of PF 05297909 for reduction in CSF levels of Abeta40, Abeta42, and/or AbetaX via estimation of the IC50 from a population PK/PD (PPK/PD) model
时间窗: Day 0 to Day 3
Plasma area under the curve infinity (AUCinf) pharmacokinetic parameter
时间窗: Day 1 to Day 3
Plasma half-life (t1/2) pharmacokinetic parameter
时间窗: Day 1 to Day 3
Plasma apparent volume of distribution (Vz/F) pharmacokinetic parameter
时间窗: Day 1 to Day 3
CSF concentration summary by time point for PF 05297909.
时间窗: Day 1 to Day 3
Change from baseline in CSF levels of Abeta40
时间窗: Day 1 to Day 3
Change from baseline in CSF levels of Abeta42
时间窗: Day 1 to Day 3
Change from baseline in CSF levels of AbetaX
时间窗: Day 1 to Day 3
Change from baseline in CSF levels of sAPPalpha
时间窗: Day 1 to Day 3
Change from baseline in CSF levels of sAPPbeta.
时间窗: Day 1 to Day 3
次要结局
未报告次要终点