NCT02138500已完成1 期
A Phase 1, Open-label Study To Evaluate Central Occupancy Of The Benzodiazepine Binding Site Of Gabaa Receptors By Positron Emission Tomography (Pet) With Ligand [11c]Flumazenil Following Single Dose Of Pf-06372865 In Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- GABAA RO in the whole brain
研究概览
简要总结
This study will see how PF-06372865, an experimental drug distributes in the brain after one dose of PF-06372865 is administered orally to healthy volunteer subjects. The study will also evaluate the safety and tolerability of PF-06372865in these subjects and will measure the level of PF-06372865 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
- •Healthy male subjects and female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- •Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
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 the time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
- •Known or suspected sensitivity to flumazenil and other benzodiazepines.
研究组 & 干预措施
Cohort 1: PF-06372865 10 mg
Experimental
干预措施: PF-06372865 (Drug)
Cohort 2: PF-06372865 TBD dose
Experimental
干预措施: PF-06372865 (Drug)
Cohort 3: PF-06372865 TBD dose
Experimental
干预措施: PF-06372865 (Drug)
结局指标
主要结局
GABAA RO in the whole brain
时间窗: Change from baseline to days 1 and 2
Average plasma concentration of PF-06372865 in post-dose PET scans after single oral doses of PF-06372865
时间窗: Change from baseline to days 1 and 2
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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