A Phase 1, Randomised, Single-center, Single-dose, Placebo-controlled, 3-Way Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability of a Lipid Multi-particulate (LMP) Formulation and Spray-dried (SD) Formulations of Tricaprilin (TC) on Ketone Body Production (Part 1). Addendum to Include a 2-way Crossover to Compare the Pharmacokinetics, Safety and Tolerability of Two Spray-dried (SD) Formulations of Tricaprilin (TC) on Ketone Body Production (Part 2)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single-dose administration of each of tricaprilin formulations and the placebo formulation, in healthy, male volunteers (for Part 1 and 2)
研究概览
简要总结
Phase 1, Single-center, Open-label Study, Healthy Adult Male Subjects.
Part 1:Single-dose, Placebo-controlled, 3-Way Crossover PK Study
Part 2: Single dose 2-way comparator PK Study
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male 18 - 50 years of age, inclusive, at Screening.
- •Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening.
- •Agrees to comply with study procedures.
- •Continuous non smoker who has not used nicotine containing products or smoking no more than 10 cigarettes per week for at least 3 months prior to Screening and will not use them throughout the study.
- •A non-vasectomized subject must agree to use a condom or abstain from sexual intercourse during the study. No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to Screening. A subject who has been vasectomized less than 4 months prior to Screening must follow the same restrictions as a non-vasectomized male.
- •Subject is able and willing to consume a prescribed full breakfast on at least 3 occasions. Subject does not have specific dietary requirements (vegetarian, vegan, lactose-free, low-fat, etc.).
- •Subject is not consuming a ketogenic diet (defined by consumption of < 50 gm carbohydrates per day).
- •Has given voluntary, written informed consent to participate in the study.
- •For Cohort 1, the Chinese subjects are restricted to being of Chinese heritage (irrespective of country of residence) and defined as all 4 grandparents of the subject must be Chinese (for Part 1 only).
排除标准
- •History or presence of alcoholism or substance abuse disorder within the last year.
- •Positive urine drug screen at Screening or Check-in.
- •Subject is currently actively using MCTs, ketone esters, or other ketogenic products or is following a ketogenic diet.
- •Clinically significant abnormal laboratory results at Screening.
- •Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing, administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.
- •Subject has a known allergy to the study drug's active or inactive ingredients.
- •Subject has been following a ketogenic diet (or other diet incompatible with the on-study diet), in the opinion of the investigator.
- •Unable to refrain from, or anticipates the use of, any drug including prescription and non-prescription medications, herbal remedies or vitamin supplements beginning 14 days prior to the first dose and throughout the study, unless deemed acceptable by the PI. Paracetamol (up to 4g per 24-hour period) or ibuprofen (up to 1,200 mg per 24-hour period) may be permitted during the study.
- •Has had alcohol 48 hours prior to Day -1 of Period
- •Any other condition which, in the investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
研究组 & 干预措施
AC-SD-03 (for Part 1)
Tricaprilin SD formulation, single dose (20g tricaprilin). Administered orally.
干预措施: Tricaprilin (Drug)
AC-LMP-01 (for Part 1)
Tricaprilin LMP formulation, single dose (20g tricaprilin). Administered orally.
干预措施: Tricaprilin (Drug)
AC-SD-03P (for Part 1)
Placebo formulation, single dose. Administered orally
干预措施: Placebo (Drug)
AC-1202 (for Part 2)
Tricaprilin SD formulation, single dose (20g caprylic triglyceride). Administered orally.
干预措施: Tricaprilin (Drug)
AC-SD-03 (for Part 2)
Tricaprilin SD formulation, single dose (20g tricaprilin). Administered orally.
干预措施: Tricaprilin (Drug)
结局指标
主要结局
Safety and tolerability of single-dose administration of each of tricaprilin formulations and the placebo formulation, in healthy, male volunteers (for Part 1 and 2)
时间窗: 11 days
Number of subjects with treatment related adverse events as assessed by CTCAE
Pharmacokinetics (PK) parameters of Total Ketones, Tricaprilin and Octanoic acid levels after single dose of each of tricaprilin formulations and the placebo formulation using Cmax (for Part 1 and 2)
时间窗: 1 day
Cmax will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate), Tricaprilin and Octanoic Acid Levels. Cmax = Cmax is maximum concentration, determined directly from individual concentration-time data.Summary statistics will be generated for each PK parameter.
Pharmacokinetics (PK) parameters of Total Ketones, Tricaprilin and Octanoic acid levels after single dose of each of tricaprilin formulations and the placebo formulation using AUC(0-t) (for Part 1 and 2)
时间窗: 1 day
AUC(0-t) will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate), Tricaprilin and Octanoic Acid Levels. AUC (0-t) = Area under the concentration-time curve from 0 to last quantifiable concentration. Summary statistics will be generated for each PK parameter.
Pharmacokinetics (PK) parameters of Total Ketones, Tricaprilin and Octanoic acid levels after single dose of each of tricaprilin formulations and the placebo formulation using Tmax (for Part 1 and 2)
时间窗: 1 day
Tmax will be calculated from PK concentrations of Total Ketones (B-hydroxybutyrate and Acetoacetate), Tricaprilin and Octanoic Acid Levels. Tmax = Time to reach maximum observed concentration, determined directly from individual concentration-time data.Summary statistics will be generated for each PK parameter.
次要结局
- ApoE4 Genotyping (for Part 1 only)(1 day)