An Open-Label, Randomized, Crossover Study to Assess the Bioavailability of Dexpramipexole Administered in Soft Food and Water, and in Intact Tablet Form in the Fasted and Fed States in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- PK parameters of dexpramipexole including maximum plasma concentration (Cmax) and the area under the plasma concentration-time curve over time from 0 to infinity (AUC0-inf) of dexpramipexole.
研究概览
简要总结
To assess the bioavailability of dexpramipexole when mixed in soft food and water, and in intact tablet form in the fasted and fed states in healthy volunteers.
详细描述
The effect of food on dexpramipexole bioavailability following administration of the proposed commercial formulation (capsule-shaped tablet) at the anticipated therapeutic dose (150 mg twice daily) has not been studied. Therefore, this study has been designed to evaluate the effect of a standard high-fat, high-calorie meal on dexpramipexole bioavailability following administration of a single 150 mg dose in healthy volunteers, consistent with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) recommendations.
Additionally, patients with ALS can have difficulty swallowing tablets, necessitating alternative methods of administration for the drug. Therefore, this study has also been designed to evaluate the bioavailability of dexpramipexole mixed with water or crushed in soft food (applesauce).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who, in the opinion of the Investigator, are healthy as determined by pre-study medical history, physical examination and 12-lead ECG.
- •Adult males/females aged 18 to 55 years inclusive.
- •Male subjects and female subjects of childbearing potential must practice effective contraception during the study and 90 days after their last dose of study drug.
排除标准
- •History of malignant disease, including solid tumors and hematologic malignancies.
- •History of any clinically significant endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases, as determined by the Investigator.
- •Surgery within 90 days prior to check in.
研究组 & 干预措施
Sequence 1 - tablet-fast
150 mg Dexpramipexole (intact tablet) single dose under fasted condition
干预措施: Dexpramipexole (Drug)
Sequence 2 - tablet-fed
150 mg Dexpramipexole (intact tablet) single dose under fed condition
干预措施: Dexpramipexole (Drug)
Sequence 3 - water-fast
150 mg Dexpramipexole single dose dispersed in water under fasted condition
干预措施: Dexpramipexole (Drug)
Sequence 4 - apple-fast
150 mg Dexpramipexole single dose crushed and mixed in applesauce under fasted condition
干预措施: Dexpramipexole (Drug)
结局指标
主要结局
PK parameters of dexpramipexole including maximum plasma concentration (Cmax) and the area under the plasma concentration-time curve over time from 0 to infinity (AUC0-inf) of dexpramipexole.
时间窗: zero to 48 hours post-dose
次要结局
- Time to the maximum plasma concentration (Tmax), the area under the plasma concentration-time curve over time from 0 to t (AUC0-t) and terminal half-life (t½) of dexpramipexole.(zero to 48 hours post-dose)