A Phase 1, Open-label Study of PIPE-307 to Determine Muscarinic Type I Receptor (M1AChR) Occupancy Parameters by [11C] PIPE-307 PET Imaging in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours
研究概览
简要总结
This is a Phase 1, single-center, open-label, adaptive-design PET study to investigate the occupancy of brain muscarinic Type 1 receptors (M1AChR) by PIPE-307 in healthy volunteers.
详细描述
This is a Phase 1, single-center, open-label, adaptive-design study to investigate the occupancy of brain M1AChR after a single oral dose of PIPE-307 in healthy volunteers by positron emission tomography (PET) using the radioligand [11C] PIPE-307.
This study will have an adaptive design to adequately evaluate the relationship between PIPE-307 exposure and brain M1AChR occupancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Clinically relevant abnormal findings at the screening assessments
- •Clinically relevant abnormal medical history or concurrent medical condition
- •Acute or chronic illness
- •Contraindications to MRI, CT, PET, or arterial cannulation procedures
- •Significant exposure to research related radiation or other exposure (defined as ICRP category IIb or no more than 10 mSv)
- •Positive tests for hepatitis B surface antigen (HBsAg) & Hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody
- •Drug or alcohol abuse
- •Smoke more than 10 cigarettes daily
- •Loss of more than 400 mL blood
- •Vital signs or ECGs outside the acceptable range
研究组 & 干预措施
PIPE-307
Subjects will receive an oral dose of PIPE-307 and 3 intravenous injections of [11C] PIPE- 307.
干预措施: PIPE-307 (Drug)
结局指标
主要结局
M1AChR receptor occupancy as determined by regional total volume of distribution (VT) of [11C] PIPE-307 at 24 hours
时间窗: 24 hours
次要结局
未报告次要终点