A Phase 1, Open-label Adaptive Design Study To Evaluate Pde10 Enzyme Occupancy As Measured By Positron Emission Tomography (Pet) Following Single Oral Dose Administration Of Pf-02545920 In Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Central PDE10A enzyme occupancy values in the striatum.
研究概览
简要总结
This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography after a single dose of PF-02545920 in Healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male volunteers
排除标准
- •History of orthostatic hypotension
- •History of prior radiation exposure for research purposes, or radiation therapy
研究组 & 干预措施
Cohort 1 - 20 mg
Cohort will include 4 HVs/completers who will receive a single 20 mg dose of PF-02545920.
干预措施: 20 mg PF-02545920 (Drug)
Cohort 2 ( adaptive dose, optional)
Cohort 2 will include 4 HVs/completers who will receive a single dose of PF-02545920. The dose will be selected based on the results obtained for Cohort 1.
干预措施: PF-02545920 (Drug)
Cohort 3 ( adaptive dose, optional)
Cohort 3 will include 4 HVs/completers who will receive a single dose of PF-02545920. The dose will be selected based on the results obtained for Cohort 1.
Dose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg. This cohort is optional
干预措施: PF-02545920 (Drug)
结局指标
主要结局
Central PDE10A enzyme occupancy values in the striatum.
时间窗: Day 10
Using Positron Emission Tomography and a radiotracer (MNI-659) for PF-02545920, the central PDE10A enzyme occupancy values will be measured in the striatum at different single oral doses of PF-02545920.
次要结局
- Central PDE10A enzyme occupancy values in the globus pallidus, in the caudate and in the putamen (separately).(Day 10)
- Maximum Observed Plasma Concentration (Cmax)(Day 10)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(Day 10)
- Average serum concentration(Day 10)