NCT05292040已完成1 期
An Adaptive Design, Phase 1, Open-label Study to Investigate Receptor Occupancy in Brain After Single Oral Doses of LY3857210 as Measured by Positron Emission Tomography (PET) With the Radioligand [18F]-LY3818850 in Healthy Participants
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
- 10
- 试验地点
- 1
- 主要终点
- Change from baseline in brain receptor occupancy (RO) of LY3857210 measured by [18F]-LY3818850 PET scan
研究概览
简要总结
The main purpose of this study is to evaluate the presence of study drug LY3857210 in the brain measured by positron emission tomography (PET) with the radioligand [18F]-LY3818850 in healthy participants. The safety and tolerability of LY3857210 will also be evaluated. The study will last up to approximately 6 weeks for each participant and may include up to four visits to the study center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 male or female participants as determined by medical evaluation
- •Have body weight ≥ 45 kilograms (kg) and body mass index (BMI) within the range 18.5 to 32.0 kilograms per square meter (kg/m²) (inclusive)
- •Are males and in agreement to follow contraceptive requirements, or women of non-child-bearing potential
排除标准
- •Have contraindications to undergoing magnetic resonance imaging (MRI) examination including but not limited to implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips, and other medical implants that have not been certified for head MRI
- •Have clinically significant findings on the screening MRI scan, as judged by the investigator
- •Suffer from claustrophobia and would be unable to tolerate the confined spaces of MRI or PET camera
研究组 & 干预措施
LY3857210
Experimental
Single doses of LY3857210 administered orally.
干预措施: LY3857210 (Drug)
结局指标
主要结局
Change from baseline in brain receptor occupancy (RO) of LY3857210 measured by [18F]-LY3818850 PET scan
时间窗: Baseline through study completion, up to approximately 6 weeks
Change from baseline in brain RO of LY3857210 measured by \[18F\]-LY3818850 PET scan
次要结局
未报告次要终点
研究者
研究点 (1)
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