NCT02288845已完成2 期
An Open-Label Positron Emission Tomography (PET) Study to Demonstrate Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of ITI-007 in Stable Schizophrenia Patients
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Brain Receptor Occupancy as Measured by Positron Emission Tomography
研究概览
简要总结
The purpose of this study is to determine the relationship between ITI-007 dose, plasma levels and brain receptor occupancy in patients with stable schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with schizophrenia who are drug-free with regard to their antipsychotic medication
- •In clinical remission and free from acute exacerbation of their psychosis
- •In good health
排除标准
- •Clinically significant medical conditions considered inappropriate for trial participation
研究组 & 干预措施
ITI-007
Experimental
ITI-007 formulated capsule will be administered orally once daily for up to 14 days in up to 14 subjects.
干预措施: ITI-007 (Drug)
结局指标
主要结局
Brain Receptor Occupancy as Measured by Positron Emission Tomography
时间窗: Up to 14 days
次要结局
- Safety and Tolerability as Measured by Number of Participants with Adverse Events(Up to 14 days)
研究者
研究点 (1)
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