A Phase I, Open-label, Fixed-order, Single-dose, 2-Part, Crossover Study to Evaluate the Pharmacokinetics of a Formulation of Tricaprilin (AC-SD-01) Including the Effect of Food on Ketone Body Production in Caucasians and Asians
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- B-hydrodxybutyrate
研究概览
简要总结
This is a Phase I, single center, open label, fixed-order, crossover, food-effect, pharmacokinetic (PK) study recruiting healthy, adult, male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male, ages 18 - 55
- •Able to consume a regular diet and one high fat meal; no specific dietary requirements
- •Cohort 2 (Asian subject population) restricted to being of Japanese or Chinese heritage
排除标准
- •Presence of any illness or condition that, in the opinion of the investigator might confound the study results or poses risk to the subject
- •Has been on a ketogenic diet as supported by review of a food diary
- •Has positive Urine Drug Screen or alcohol results at Screening
研究组 & 干预措施
Cohort 1, Period 1
Study drug administered concurrently with a standard meal
干预措施: tricaprilin (Drug)
Cohort 1, Period 1
Study drug administered concurrently with a standard meal
干预措施: standard meal (Other)
Cohort 1, Period 2
Study drug administered 30 minutes after a standard meal
干预措施: tricaprilin (Drug)
Cohort 1, Period 2
Study drug administered 30 minutes after a standard meal
干预措施: standard meal (Other)
Cohort 1, Period 3
Study drug administered 30 minutes after a high-fat meal
干预措施: tricaprilin (Drug)
Cohort 1, Period 3
Study drug administered 30 minutes after a high-fat meal
干预措施: high-fat meal (Other)
Cohort 1, Period 4
Study drug administered after an overnight fast
干预措施: tricaprilin (Drug)
Cohort 2, Period 1
Study drug administered 30 minutes after a standard meal (Asian)
干预措施: tricaprilin (Drug)
Cohort 2, Period 1
Study drug administered 30 minutes after a standard meal (Asian)
干预措施: standard meal (Other)
Cohort 2, Period 2
Study drug administered after an overnight fast (Asian)
干预措施: tricaprilin (Drug)
Cohort 2, Period 2
Study drug administered after an overnight fast (Asian)
干预措施: overnight fast (Other)
结局指标
主要结局
B-hydrodxybutyrate
时间窗: 1 day
AUC 0-last
Total ketones
时间窗: 1 day
Maximum Plasma Concentration (Cmax)
B-hydroxybutyrate
时间窗: 1 day
Cmax
Acetoacetate
时间窗: 1 day
Cmax
次要结局
- octanoic acid(1 day)
- Computerized Cognitive Battery - Psychomotor Function(1 day)
- Computerized Cognitive Battery - Attention(1 day)
- Computerized Cognitive Battery - Episodic Memory(1 day)
- tricaprilin(1 day)
- Computerized Cognitive Battery - Working Memory(1 day)