Open Label Adaptive Design Study To Evaluate D1 Receptor Occupancy (ro) Following Single Dose Of Pf-06412562, Using Positron Emission Tomography (Pet) With Ligand [11c]sch23390 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
- 5
- 试验地点
- 1
- 主要终点
- PF-06142562 plasma exposure and RO in the striatum
研究概览
简要总结
This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 In healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 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
- •Evidence or history of clinically significant hepatic, renal, cardiovascular, endocrine, hematologic, gastrointestinal, pulmonary, neurologic, oncologic, psychiatric, or allergic disease Any condition possibly affecting drug absorption A positive urine drug screen
研究组 & 干预措施
Cohor 1 - 30 mg
Cohort will include approximately 4 HVs/completers who will receive a single 30 mg dose of PF-06412562.
干预措施: 30 mg PF-06412562 (Drug)
Cohort 2 ( adaptive dose, optional)
Cohort 2 will include approximately 4 HVs/completers who will receive a single dose of PF-06412562. The dose will be selected based on the results obtained for Cohort 1.
干预措施: PF-06412562 (Drug)
Cohort 3 ( adaptive dose, optional)
Cohort 2 will include approximately 4 HVs/completers who will receive a single dose of PF-06412562. The dose will be selected based on the results obtained for Cohort 1 and Cohort 2.
干预措施: PF-06412562 (Drug)
结局指标
主要结局
PF-06142562 plasma exposure and RO in the striatum
时间窗: Day 1
Using Positron Emission Tomography and a radiotracer \[11C\]SCH23390, the PF-06142562 plasma exposure and RO in the striatum (average of caudate and putamen) will be measured in healthy male subjects.
次要结局
- Maximum Observed Plasma Concentration (Cmax)(Day 1)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(Day 1)
- Area under the plasma concentration-time profile from time zero to the last plasma measurement at 4 hours (AUC0-4)(Day 1)
- Average plasma concentration over 4 hours (Cav,0-4)(Day 1)