A Single-Centre, Non-Randomised, Open Label, Positron Emission Tomography Imaging Study to Assess Occupancy of α5-Containing GABAA Receptors by RO5186582 in Healthy Volunteers of Japanese Origin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Percentage of Brain α5 Subunit-Containing GABAA Receptors Occupied by Basmisanil (Receptor Occupancy) Following a Single Dose of Basmisanil in Selected Regions of Interest (ROIs) Assessed by PET Imaging
研究概览
简要总结
This study will evaluate the relationship between basmisanil plasma concentrations and the occupancy of Gamma-Amino Butyric Acid A (GABAA) receptor subtypes containing an alpha5 (α5) subunit in healthy Japanese volunteers. Each participant will have two post-screening imaging sessions. In the first imaging session, participants will have a baseline Positron Emission Tomography (PET) scan. In the second imaging session, participants will receive a single oral dose of basmisanil, followed by two on-treatment PET scans at about 4 and 10 hours post-dose.
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
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female Japanese healthy volunteer, who was born in Japan, has 4 ethnically Japanese grandparents and has lived outside Japan for no longer than 5 years
- •A body mass index (BMI, Quetelet index) in the range 18.0 to 32.0 kilograms per square meter (kg/m^2)
- •Willingness and ability to comply with study restrictions
排除标准
- •A history of epilepsy, convulsions or significant head injury, or other structural brain abnormality
- •Pregnant or lactating or not using acceptable contraception
- •Presence or history of severe adverse reaction to any drug or a history of sensitivity to basmisanil or the PET radioligand (RO15-4513)
- •Significant exposure to radiation within the previous 12 months
- •Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
研究组 & 干预措施
Basmisanil in Japanese Healthy Volunteers
Japanese healthy volunteers will receive a single oral dose of RO5186582 within 15 minutes after completing a standard meal.
干预措施: Basmisanil (Drug)
结局指标
主要结局
Percentage of Brain α5 Subunit-Containing GABAA Receptors Occupied by Basmisanil (Receptor Occupancy) Following a Single Dose of Basmisanil in Selected Regions of Interest (ROIs) Assessed by PET Imaging
时间窗: Day 1
Correlation Between Basmisanil Plasma Concentration and Occupancy of Brain α5 Subunit-Containing GABAA Receptors
时间窗: Day 1
次要结局
- Percentage of Participants With Adverse Events(From Baseline up to 7-14 days)
- Brain GABAA Receptor α5 Subunit Levels in Selected ROIs Assessed by PET Imaging(Day 1)