NCT02006290已完成1 期
A Phase 1b, Randomized, Subject And Investigator-Blinded, Sponsor-Open, Placebo Controlled, Cross-Over Efficacy, Safety And Tolerability Study Of Single Oral Split Dose Administration Of PF-06412562 In Subjects With Parkinson's Disease
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
- 19
- 试验地点
- 1
- 主要终点
- Finger tapping speed
研究概览
简要总结
The B7441003 study will assess PF-06412562 for motor benefit in Parkinson's disease subjects. Safety, tolerability and PK of PF-06412562 in Parkinson's disease subjects will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects with a diagnosis of idiopathic Parkinson's disease.
- •Daily L-dopa dose between 300 and 1200 mg.
- •MBRS score >1.
排除标准
- •Surgical intervention for Parkinson's disease.
- •History of troublesome dyskinesias.
- •Any significant AXIS I psychiatric disease.
研究组 & 干预措施
1
Experimental
干预措施: PF-06412562 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Finger tapping speed
时间窗: 12 hours
maximum percent improvement from baseline in finger tapping speed as measured by the Kinesia Technology
次要结局
- Plasma Decay Half-Life (t1/2)(0, 0.5, 1, 2, 4, 8, 12, 24 hours)
- Apparent Volume of Distribution (Vz/F)(0, 0.5, 1, 2, 4, 8, 12, 24 hours)
- Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS)(24 hours)
- Maximum Observed Plasma Concentration (Cmax)(0, 0.5, 1, 2, 4, 5,8,12, 24 hours)
- Apparent Oral Clearance (CL/F)(0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(0, 0.5, 1, 2, 4, 0, 0.5, 1, 2, 4, 8, 12, 24 hours)
- Mean Residence Time (MRT)(0, 0.5, 1, 2, 4, 8, 12, 24 hours)
研究者
研究点 (1)
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