NCT01935830已完成早期 1 期
Efavirenz and Ritonavir Influence on Human Brain Levo-acetylmethadol (LAAM) Disposition Assessed Using PET Imaging
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- cerebral [11C]LAAM distribution volume
研究概览
简要总结
The purpose of this study is to determine the effects of the antiretroviral drugs efavirenz and ritonavir on human brain LAAM disposition in vivo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
LAAM arm
Experimental
- [11C]LAAM 15-20 mCi (maximum administered mass of 10 ug)
- Efavirenz, oral capsules, 600 mg
- Ritonavir, oral capsules, 100 mg
干预措施: [11c] LAAM (Radiation)
LAAM arm
Experimental
- [11C]LAAM 15-20 mCi (maximum administered mass of 10 ug)
- Efavirenz, oral capsules, 600 mg
- Ritonavir, oral capsules, 100 mg
干预措施: Ritonavir (Drug)
LAAM arm
Experimental
- [11C]LAAM 15-20 mCi (maximum administered mass of 10 ug)
- Efavirenz, oral capsules, 600 mg
- Ritonavir, oral capsules, 100 mg
干预措施: Efavirenz (Drug)
结局指标
主要结局
cerebral [11C]LAAM distribution volume
时间窗: approximately 3 months
Blood tests, MRI and PET data analysis and interpretation
次要结局
未报告次要终点
研究者
研究点 (1)
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