(+)-Alpha-Dihydrotetrabenazine Phase I
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- VMAT2 occupancy by HTBZ determined by positron emission tomography (PET) scanning
研究概览
简要总结
This research study is intended to determine the initial safety and tolerability of single oral doses of the drug (+)-alpha-dihydrotetrabenaxine (HTBZ) in normal volunteers. HTBZ is believed to be the active ingredient in the FDA-approved drug tetrabenazine (TBZ, brand name Xenazine), prescribed for treatment of involuntary movements in patients with Huntington's chorea. TBZ is a mixture of closely-related compounds (isomers) and is readily metabolized (converted) in the human body to HTBZ and related isomers. Investigators believe that HTBZ, the drug to be studied in this research, is the active ingredient in TBZ. The present study will confirm safety and tolerability of HTBZ and will investigate its expected effects on brain sites that are the target of TBZ therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •able to provide informed consent
排除标准
- •pregnant or lactating female subjects
- •Subjects taking medications that interfere with VMAT2 (ex amphetamine)
- •History of significant neurologic or psychiatric conditions
- •Significant active medical conditions
- •Alcohol or illicit substance use or dependence
研究组 & 干预措施
dose escalation
Single dose administration of (+)-alpha-Dihydrotetrabenazine (HTBZ), escalating dosage amounts 7.5 - 30 mg orally
干预措施: HTBZ (Drug)
结局指标
主要结局
VMAT2 occupancy by HTBZ determined by positron emission tomography (PET) scanning
时间窗: 60 minutes post-administration of HTBZ
次要结局
未报告次要终点
研究者
Kirk A. Frey
Professor of Radiology
University of Michigan