NCT01232439已完成1 期
Assessment of Brain Kappa Opioid Receptor Occupancy After Single Oral Doses of LY2456302 as Measured by PET With Radioligand LY2879788 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
- 13
- 试验地点
- 1
- 主要终点
- Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET)
研究概览
简要总结
To measure the occupancy of brain kappa opioid receptors after single oral doses of LY2456302.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female
- •Have clinical laboratory tests within normal reference ranges
- •Have arterial and venous access sufficient to allow blood sampling
排除标准
- •Currently enrolled in, or discontinued within the last 30 days from a clinical trial
- •History of severe allergies or multiple adverse drug reactions
- •Have an abnormal ECG at screening visit
- •Have abnormal sitting blood pressure
- •Have an increased risk of seizures
- •Current suicidal ideation
- •Positive test for HIV, hepatitis C, or hepatitis B
- •Women who are breast feeding
- •Smoke more than 10 cigarettes per day, or equivalent
- •Drink more than 5 cups of coffee per day, or equivalent
- •Have a history of head injury
- •Unable to undergo a MRI
- •Suffer from claustrophobia
研究组 & 干预措施
opioid receptor kappa antagonist
Experimental
干预措施: opioid receptor kappa antagonist (Drug)
结局指标
主要结局
Change in brain kappa opioid receptor occupancy (RO) by positron emission tomography (PET)
时间窗: Baseline, after single dose of study drug
次要结局
- Pharmacokinetics, area under the curve (AUC)(Days 1 and 2)
- Number of participants with clinically significant effects(Baseline to study completion)
- Pharmacokinetics, concentration maximum (Cmax)(Days 1 and 2)
研究者
研究点 (1)
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