A Double Blind, Randomized, Single Dose, Placebo Controlled Study of the Pharmacokinetics and Side Effects of the mGlu5 Antagonist Fenobam in Adult Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pharmacokinetic data after oral administration of 50, 100 or 150 mg of fenobam in groups of healthy individuals.
研究概览
简要总结
This is a randomized, blinded, parallel group, placebo-controlled trial on 32 evaluable healthy male and non-pregnant female, 18-50 year old volunteers. The investigators goal is to observe the pharmacokinetics of fenobam after oral administration of 50, 100 or 150 mg in groups of healthy individuals and to compare the side effects and tolerability of a single dose of fenobam with placebo.
详细描述
Treatment regimen 1: Fenobam [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate], oral administration of one 50 mg gelatin capsule.
Treatment regimen 2: Fenobam, oral administration of one 100 mg gelatin capsule.
Treatment regimen 3: Fenobam, oral administration of one 150 mg gelatin capsule.
Treatment regimen 4: Placebo (lactose), oral administration of one 150 mg gelatin capsule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fenobam 50 mg
Treatment regimen 1: Fenobam [1-(3-chlorophenyl)-3-(1-methyl-4-oxo-2-imidazolidinylidine) urea hydrate], oral administration of one 50 mg gelatin capsule.
干预措施: Fenobam (Drug)
Fenobam 100 mg
Treatment regimen 2: Fenobam, oral administration of one 100 mg gelatin capsule.
干预措施: Fenobam (Drug)
Fenobam 150 mg
Treatment regimen 3: Fenobam, oral administration of one 150 mg gelatin capsule.
干预措施: Fenobam (Drug)
Placebo arm
Treatment regimen 4: Placebo (lactose), oral administration of one 150 mg gelatin capsule.
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetic data after oral administration of 50, 100 or 150 mg of fenobam in groups of healthy individuals.
时间窗: 24 hours
Blood samples will be drawn periodically before and after fenobam/placebo administration for approximately 10 hours (at approximately 30, 60, 120, 180, 240, 300, 360 and 600 minutes) and one more time the next day (day 2).
次要结局
- Number of participants with adverse events as a measure of tolerability(1 week)
研究者
Laura Cavallone
Assistant Professor of Anesthesiology
Washington University School of Medicine