A Randomized, Double-Blind, Placebo Controlled, Sponsor Open, Phase 1b Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-04958242 In Psychiatrically Stable Subjects With Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4
研究概览
简要总结
To evaluate the safety and tolerability of multiple, ascending doses of PF-04958242 administered orally to psychiatrically stable subjects with schizophrenia receiving antipsychotic and adjunctive medication.
详细描述
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Psychiatrically stable subjects with schizophrenia
- •Evidence of stable schizophrenia symptomatology ≥ 3 months
- •Score on MCCB Letter-number span + Spatial span subtest < 40.
排除标准
- •History of seizures or of a condition with risk of seizures
- •History of abnormal EEG.
- •Pregnant or nursing females, and women of child bearing potential
研究组 & 干预措施
PF-04958242
干预措施: PF-04958242 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 4
时间窗: Day 4
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24 hours after dosing on Day 1
时间窗: Day 1 - Day 2
Composite of Pharmacokinetics measured pre-dose and 1 hour post-dose on Day 7
时间窗: Day 7
Composite of Pharmacokinetics measured at 0.25, 0.5, 0.75, 1, 2, 3, 4, 8, 12, 24, 48, 72, 120 hours after dosing on Day 14
时间窗: Day 14 - Day 17
Composite of urine Pharmacokinetics measured for 24 hours post-dose on Day 14
时间窗: Day 14 - Day 15
次要结局
- Columbia Suicide Severity Rating Scale(Day 0, 1, 7, 14, 17, 23)
- Cogntion - CogState(Day 0, 1, 6, 13)
- Cognition - Matrics Consensus Cognition Battery(Day 0, 1, 6, 13)
- Drug Effect Questionnaire liking scale(Day, 1, 14)
- Cognitive training(Days 0 - 13)