Assessment of Brain O-GlcNAcase (OGA) Enzyme Occupancy After Single Oral Doses of LY3372689 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]LSN3316612 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Percent OGA EO
研究概览
简要总结
This study uses imaging to evaluate how LY3372689 binds to a protein in the brain. This study will be conducted in healthy participants and will last up to approximately 25 days after enrollment. Screening must be completed within 28 days prior to enrollment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overtly healthy males or females who cannot get pregnant
- •Have a body mass index (BMI) of at least 18.5 kilogram per square meter (kg/m²), inclusive, at screening
- •Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
- •Have veins and arteries suitable for protocol required blood sampling
排除标准
- •Have a history of head injury or contraindications to undergoing magnetic resonance imaging (MRI) examination
- •Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- •Have previously participated or withdrawn from this study
- •Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking for study procedure
- •Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate or could interfere with understanding the results of the study
- •Have long exposure to sunlight routinely or use tanning beds regularly
- •Participate in regular vigorous exercise
研究组 & 干预措施
LY3372689 + [18F]LSN3316612
LY3372689 administered orally followed by [18F]LSN3316612 PET tracer administered intravenously (IV) approximately 2 - 72 hours later.
干预措施: LY3372689 (Drug)
LY3372689 + [18F]LSN3316612
LY3372689 administered orally followed by [18F]LSN3316612 PET tracer administered intravenously (IV) approximately 2 - 72 hours later.
干预措施: [18F]LSN3316612 (Diagnostic Test)
结局指标
主要结局
Percent OGA EO
时间窗: Postdose Scan 2 (Days 2 - 4)
Percent OGA EO
Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO)
时间窗: Predose Scan (Days -14 to -1)
Percent OGA EO
次要结局
未报告次要终点