A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo-controlled, Single Ascending Dose Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Idiopathic Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 18
- 试验地点
- 8
- 主要终点
- Number of participants with abnormal clinically significant laboratory measurements
研究概览
简要总结
This is a study with two sequential cohorts, each with three treatment periods. Single doses of PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose projected to be under the current limits for drug concentration. Each cohort will aim to achieve approximately 9 completers. Primary endpoint is safety and tolerability, secondary endpoint is MDS-UPDRS part III.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •L-DOPA-responsiveness
- •Hoehn & Yahr Stage II-III inclusive
- •Experiencing motor fluctuations
- •Stable daily dose of L-DOPA of at least 300 mg
- •Females on non-childbearing potential and male subjects
排除标准
- •History of troublesome dyskinesias
- •History of surgical intervention for Parkinson's disease
研究组 & 干预措施
Cohort 1
Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.
干预措施: PF-06649751 (Drug)
Cohort 1
Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.
干预措施: Trimethobenzamide Hydrochloride (Drug)
Cohort 1
Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.
干预措施: Placebo (Drug)
Cohort 2
Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.
干预措施: PF-06649751 (Drug)
Cohort 2
Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.
干预措施: Trimethobenzamide Hydrochloride (Drug)
Cohort 2
Three single doses over three periods. For each of the three periods, subjects will be crossed-over from placebo or PF-06649751. Each PF-06649751 dose is separated by at least one week.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with abnormal clinically significant laboratory measurements
时间窗: Day 1 through 61
Number and proportion of subjects with Adverse Events (AEs)
时间窗: Day 1 through 61
Number of participants with vital signs data that meet criteria of potential clinical concern
时间窗: Day 1 through 61
Number of participants with ECG data that meet criteria of potential clinical concern
时间窗: Day 1 through 61
C-SSRS (suicidality assessment)
时间窗: Day 1 through 61
次要结局
- MDS-UPDRS part III(Day 1, Periods 1-3)