NCT00765115已完成1 期
Assessment of LY450139-Mediated Inhibition of Amyloid Beta Formation Determined by 13C6-Leucine In Healthy Subjects
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
- 27
- 试验地点
- 1
- 主要终点
- To test hypothesis that LY450139, a gamma-secretase inhibitor, will reduce the rate of synthesis of 13C6-leucine-labeled Aβ (newly synthesized) in lumbar cerebrospinal fluid (CSF).
研究概览
简要总结
To test that LY450139, a gamma-secretase inhibitor, will reduce the rate of newly synthesize Amyloid Beta by determining the amount of newly synthesized 13C6 leucine-labeled Amyloid Beta in lumbar cerebrospinal fluid from LY450139 treated subjects compared with placebo treated subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers: Men within the ages of 21 and 50
排除标准
- •Have serious or unstable medical conditions
- •Have a history of serious infections affecting the brain or head trauma resulting in protracted loss of consciousness within the last 5 years or multiple episodes of head trauma
- •Have a history of primary or recurrent malignant disease
- •Have a recent laboratory result indicating a clinically significant laboratory abnormality as determined by the investigator
- •Have a history of chronic alcohol or drug abuse within the past 5 years
- •Have a known history of Human immunodeficiency virus (HIV), afebrile seizures, or clinically significant multiple drug allergies
- •Are judged clinically by the investigator to be at serious risk for suicide
- •Have electrocardiogram abnormalities obtained at visit 1 that in the opinion of the investigator are clinically significant
- •Use of prescription or over the counter medications that cannot safely be discontinued within 14 days prior to visit 2
- •Have criteria that would preclude a LP such as allergy to all local anesthetics; have a local infection at the site of the LP or have any medical condition requiring treatment with warfarin or heparin.
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •Are investigator site personnel directly affiliated with this study and or immediate families.
- •Are Lilly employees
研究组 & 干预措施
1
Experimental
100 mg LY 450139 oral
干预措施: LY450139 (Drug)
2
Experimental
140 mg LY450139 oral
干预措施: LY450139 (Drug)
3
Experimental
280 mg LY450139 oral
干预措施: LY450139 (Drug)
4
Experimental
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
To test hypothesis that LY450139, a gamma-secretase inhibitor, will reduce the rate of synthesis of 13C6-leucine-labeled Aβ (newly synthesized) in lumbar cerebrospinal fluid (CSF).
时间窗: 0-36 hours post dose
次要结局
- To test the hypothesis that LY450139 has an effect on fractional clearance rate of Amyloid Beta assayed from CSF samples in LY450139-treated subjects compared to placebo-treated subjects.(0-36 hours post dose)
- To study and evaluate other biomarkers, such as sAPPB and sAPPA that may enable drug effectiveness to be predicted.(0-36 hours post dose)
- To measure concentrations of Amyloid Beta(1-40), Amyloid Beta(1-42), and leucine in CSF by mass spectrometry.(0-36 hours post dose)
- To explore the relationship between Amyloid Beta plasma decrease and Amyloid Beta synthesis rate as determined by CSF measurements.(0-36 hours post dose)
研究者
研究点 (1)
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