NCT02005991已完成1 期
A Phase 1, Open-Label Study To Evaluate 5-HT2a Receptor Occupancy As Measured By Positron Emission Tomography (PET) With Ligand [11C]MDL100907 Following Single Oral Dose Administration Of PP-05212377 (SAM-760) In Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- 5-HT2a receptor occupancy of PF-05212377 in the frontal cortex using PET
研究概览
简要总结
This study will see how PF-05212377, an experimental drug to treat symptoms from Alzheimer's Disease, distributes in the brain after one dose of PF-05212377 is administered orally to healthy volunteer subjects. The study will also evaluate the safety and tolerability of PF-05212377 in these subjects and will measure the level of PF-05212377 in the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Males and females must be at least 18 years of age and no older than 55 years of age with a Body Mass Index (BMI) must be between 17.5 and 30.
- •Subjects must sign a consent form and comply with all scheduled visits, treatment plan, lab tests and other study procedures.
排除标准
- •Females must not be pregnant, breastfeeding, or able to have children.
- •Subjects must not have a severe acute or chronic medical or psychiatric condition history or evidence of blood, kidney, glandular, lung, stomach, intestine, heart, blood vessel, liver, psychiatric, nerve, or allergic problems (including drug allergies), except mild seasonal allergies.
- •Subjects must not drink alcohol excessively or take illicit drugs.
- •Male subjects use condoms to prevent the potential transfer of drug through the semen to their partner beginning with the dose of study drug and use a highly effective method of birth control with any partner(s) of childbearing potential through 28 days after the last dose.
研究组 & 干预措施
PF-05212377 70 mg
Experimental
干预措施: PF-05212377 (Drug)
PF-05212377 20 mg
Experimental
干预措施: PF-05212377 (Drug)
PF-05212377 10 mg
Experimental
干预措施: PF-05212377 (Drug)
结局指标
主要结局
5-HT2a receptor occupancy of PF-05212377 in the frontal cortex using PET
时间窗: Days 1 and 2
Plasma PF-05212377 exposure associated with PF-05212377 5-HT2a receptor occupancy
时间窗: Days 1 and 2
次要结局
- 5-HT2a receptor occupancy of PF-05212377 in other cortical regions(Day 1 and 2)
研究者
研究点 (1)
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