NCT00876304已完成1 期
Phase 1, Investigator And Subject-Blind, Placebo-Controlled, Randomized, Sequential Group, Multiple Ascending Dose Study To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04802540 In Patients With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to subjects with schizophrenia.
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
- •Males or females of non-childbearing capacity aged 18 to 55 years inclusive
- •DSM-IV diagnosis of schizophrenia, stable symptoms for at least 3 months
- •Body mass index in the range of 18 to 40 kg/m2 and body weight>45 kg.
排除标准
- •Evidence or history of a primary DSM IV axis I diagnosis other than schizophrenia.
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
研究组 & 干预措施
PF-04802540
Experimental
干预措施: PF-04802540 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety assessments: vital signs, ECG, physical examination, laboratory tests, Columbia - Suicide Severity Rating Scale
时间窗: 22 days
Plasma concentrations of PF 04802540 and its metabolite, PF 04831035
时间窗: 12 Days
Adverse Events
时间窗: 22 Days
次要结局
- Extrapyramidal Symptom Rating Scale - Abbreviated(16 days)
- Clinical Global Impression of Severity and Improvement(16 days)
- Positive and Negative Syndrome Scale(16 days)
研究者
研究点 (1)
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