A Phase 1, Single Centre, Randomised, 2 Period Crossover Study to Determine the Effect of Food on the Pharmacokinetic Profile of a Single Dose of PBT2 Administered Orally to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve (AUC 0-t)
研究概览
简要总结
This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of PBT2 administered to healthy volunteers in the presence and absence of food.
详细描述
The study will be conducted in 2 dosing periods, with participants being randomised to receive PBT2 250 mg with or without food in the first dosing period, followed by a 7 day washout period before receiving the opposite fed/fasted condition to that allocated in the first dosing period. Pharmacokinetic samples will be collected during each dosing period, along with safety monitoring assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or females with a BMI between 19 and 30kg/m2
- •No clinically significant abnormalities
排除标准
- •Exposure to medications/drugs that interfere with metabolism of PBT2 including drugs that inhibit or induce CYP1A2)
- •Use of caffeine-containing beverages, supplements or alcohol within 72 hours of study entry
- •Significant history of depression or other psychiatric illness
- •Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion
- •unable to swallow capsules
研究组 & 干预措施
Fed Cohort
PBT2 250 mg is administered orally following a high fat breakfast
干预措施: Fed Cohort PBT2 (Drug)
Fasted Cohort
PBT2 250 mg is administered orally following a 10 hour period of fasting
干预措施: Fasted Cohort PBT2 (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve (AUC 0-t)
时间窗: prior to the initial doses on day 1 and 8 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8,10,12,16, 24, 30, 36, 48 hours post each dose
次要结局
- Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events(Up to 15 days after the first dose of PBT2)