Assessment of Brain O-GlcNAcase (OGA) Enzyme Occupancy After Multiple Oral Doses of LY3372689 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]LY3316612 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Percent O-GlcNAcase (OGA) Enzyme Occupancy (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 about 10 weeks. Screening must be completed within four weeks 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 65 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 do not have child-bearing potential
- •Have a body mass index (BMI) of greater than (>)18 to less than or equal to (≤32) kilograms 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 venous access sufficient to allow for 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- •Have previously participated or withdrawn from this study
- •Have had prior participation in other research protocols or clinical care in the preceding year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 milliSievert (mSv), which would be above the acceptable annual limit established by the US Federal Guidelines
- •Are current smokers or have used tobacco or nicotine-containing products as determined by the cotinine test
- •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
- •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 24 hours later.
干预措施: LY3372689 (Drug)
LY3372689 + [18F]LSN3316612
LY3372689 administered orally followed by [18F]LSN3316612 PET tracer administered intravenously (IV) approximately 24 hours later.
干预措施: [18F]LSN3316612 (Diagnostic Test)
结局指标
主要结局
Percent O-GlcNAcase (OGA) Enzyme Occupancy (EO)
时间窗: Approximately 2 to 96 hours following the first dose
Percent OGA EO
Percent OGA EO
时间窗: Approximately 2 to 96 hours following the last dose
Percent OGA EO
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve During the Dosing Interval (AUC[0-tau]) of LY3372689(Baseline through 24 hours)
- PK: Maximum Concentration (Cmax) of LY3372689(Baseline through 24 hours)