Subject And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, Parallel Group Study to Assess Effects of PF-04958242 on Bold Functional MRI During Working Memory Activation and Arterial Spin Labeling at Rest in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Functional Magnetic Resonance Imaging Data During Working Memory Task
研究概览
简要总结
The primary objective of this study aims to determine whether the drug affects brain activity in healthy volunteers, either when the participants are performing a memory task, or when lying at rest. Subjects will undergo a brain scan under both of these conditions after a dose of either the study drug or a placebo is administered.The secondary objective is to evaluate the safety and tolerability of the four doses of PF-04958242 administered orally to healthy adult participants.
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
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter squared (kg/m2);
- •Total body weight >50 kilograms (kg) (110 pounds [lbs]);
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);
- •Positive urine drug screen;
- •Pregnant or nursing females, and females of child bearing potential;
- •Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Placebo
Participants will receive placebo as a single oral dose.
干预措施: Placebo (Drug)
Cohort 1
Participants will receive 0.075 milligrams (mg) of PF-04958242 as a single oral dose.
干预措施: PF-04958242 (Drug)
Cohort 2
Participants will receive 0.15 mg of PF-04958242 as a single oral dose.
干预措施: PF-04958242 (Drug)
结局指标
主要结局
Functional Magnetic Resonance Imaging Data During Working Memory Task
时间窗: 59 Minutes Post-dose
Arterial Spin Labeling Data
时间窗: 39 Minutes Post-dose
次要结局
- Number of Participants Experiencing Adverse Events and Serious Adverse Events(Up to Day 11)