A Non-Randomized Open Label, Adaptive, Parallel Group, Human Positron Emission Tomography (PET) Study to Assess Occupancy of Brain alpha5-Containing GABAA Receptors of Ro7017773 Using [11C] Ro15-4513 Following Single Oral Doses in Healthy Participants
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
- Plasma Concentrations of RO7017773
研究概览
简要总结
This is a single dose (SD), non-randomized, open-label, adaptive, parallel group study with the purpose of investigating the occupancy of alpha5-containing GABAA receptors by RO7017773 in healthy participants.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy (absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemisty, serology, and urinalysis), as judged by the Investigator.
- •Males and women of non-childbearing potential (WONCBP)
排除标准
- •History of convulsions (other than benign febrile convulsions of childhood) including epilepsy, or personal history of significant cerebral trauma or CNS infections
- •Clinically significant abnormal finding from the MRI performed after the initial screening examination
- •Abnormal blood pressure, i.e, systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg
- •Abnormal pulse rate, resting pulse rate greater than 100 or less than 40 bpm
- •History or presence of clinically significant ECG abnormalities before study drug administration or cardiovascular disease
- •Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- •Positive result on hepatitis B (HBV) or hepatitis C (HCV), presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment
研究组 & 干预措施
RO7017773
The first two participants of the first cohort are anticipated to receive a single dose of RO7017773 orally. The doses to be tested in the subsequent cohorts of participants will be determined by review of PET scan, PK, and safety results from the previous dose level.
干预措施: RO7017773 (Drug)
RO7017773
The first two participants of the first cohort are anticipated to receive a single dose of RO7017773 orally. The doses to be tested in the subsequent cohorts of participants will be determined by review of PET scan, PK, and safety results from the previous dose level.
干预措施: [11C] Ro15-4513 (Other)
结局指标
主要结局
Plasma Concentrations of RO7017773
时间窗: Baseline up to 48 hrs
Percentage of Brain Alpha5-Containing GABA-A Receptors Occupied by RO7017773
时间窗: Baseline up to 48 hours (hrs)
次要结局
- Number of Participants With Adverse Events (AEs)(From treatment initiation until 14 days after the last dose of study treatment.)