A Phase 1, Two-part, Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Liquid Formulation of Tricaprilin, and Matching Placebo to Include Single-dose and Food Effect (Part A), and Titration Tolerability (Part B), in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part A)
研究概览
简要总结
The purpose of this study is to evaluate the PK, safety, and tolerability of a new liquid formulation of tricaprilin.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy males and non-pregnant, non-lactating healthy females aged 18 to 55 years inclusive at time of signing informed consent with a body weight ≥55 kg.
- •Body mass index (BMI) 18.0 to 32.0 kg/m2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.
排除标准
- •Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- •Subjects with a history of fainting, dizziness, bradycardia or hypotension as considered clinically significant by the investigator
- •Subject has a medical condition that may adversely affect taste or smell activity
研究组 & 干预措施
Part A - Food Effect Assessment
Subjects will be randomized before administration of the first dose of active or matching placebo IMP in a 1:1:1:1 ratio to 1 of 4 treatment sequences (ABCD, BACD, ABDC, BADC) so that all subjects receive Regimens A, B, C and D across the 4 periods.
干预措施: AC-OLE-01-VA (Drug)
Part B - Titration Tolerability
Subjects will be dosed BID in the morning and afternoon (approximately 5 h apart) on Days 1 to 27. Both doses of active or matching placebo IMP will be administered in the fed state either 30 min after completion of a standard-fat and calorie content breakfast or 30 min after a standardized-fat and calorie content lunch.
Participants will be randomised to either study drug or the matching placebo.
干预措施: AC-OLE-01-VA (Drug)
结局指标
主要结局
Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) after single-dose administration of tricaprilin and placebo formulations (Part A)
时间窗: 0 to 8 hours post-dose
AUC will be calculated from PK concentrations of total ketones (B-hydroxybutyrate and Acetoacetate)
Incidence of Treatment Emergent Adverse Events (Part B)
时间窗: Baseline to 28 days
Adverse event incidence will be tabulated
次要结局
- Area under the concentration-time curve (AUC) of total ketones (β-hydroxybutyrate and acetoacetate) of tricaprilin and placebo formulations following a titration scheme (Part B)(0 to 8 hours post-dose)
- Incidence of Treatment Emergent Adverse Events (Part A)(Baseline to 8 days)
- Maximum observed concentration (Cmax) of total ketones (β-hydroxybutyrate and acetoacetate) after administration of tricaprilin and placebo formulations (Part A, Part B)(0 to 8 hours post-dose)