An Open-Label, 2-Way, 2-Period Crossover Study of Orally Administered VS-6766 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of VS-6766
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-120
研究概览
简要总结
An Open-Label, 2-Way, 2-Period Crossover Study of Orally Administered VS-6766 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of VS-6766
详细描述
This is an open-label, randomized, 2-way, 2-period crossover, Food Effect study.
On Day 1 of each period, subjects will receive a single oral dose of VS-6766 administered in a 2-way crossover fashion either under fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for VS-6766 will be collected predose and postdose. There will be a washout period between doses.
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
- •Healthy, adult, male or female (of non-childbearing potential only), 18-55 years of age, inclusive, at the screening visit.
- •Must follow protocol specified contraception guidance.
- •Continuous non-smoker who has not used tobacco/nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
- •Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
- •Medically healthy with no clinically significant medical history.
- •Able to swallow capsules.
- •Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
排除标准
- •Presence of systemic or severe infection.
- •History or presence of a significant medical condition or disease which is not completely resolved.
- •History or presence of alcohol or drug abuse
- •History or presence of hypersensitivity or reaction to the study drug or related compounds.
- •History of tuberculosis.
- •Presence of any fever within 2 weeks prior to first dosing.
- •Females able to have children.
- •Females who are pregnant or lactating.
- •Presence of HIV.
- •Must be able to refrain from using any drugs, including prescription and non-prescription medications beginning 28 days prior to the first dosing.
- •Lactose Intolerance.
- •Donation of blood or significant blood loss or blood transfusion within 56 days prior to the first dosing.
- •Plasma donation within 7 days prior to the first dosing.
- •Participation in another clinical study within 30 days prior to the first dosing.
研究组 & 干预措施
Treatment A
4.0 mg VS-6766, following an overnight fast of at least 10 hours
干预措施: VS-6766 (Drug)
Treatment B
4.0 mg VS-6766, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast
干预措施: VS-6766 (Drug)
结局指标
主要结局
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-120
时间窗: 30 days
Area under plasma Concentration (AUC) from 0-120 minutes
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-t
时间窗: 30 days
Area under plasma Concentration (AUC) 0 to t
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: T1/2
时间窗: 30 days
concentration Half-life (T1/2)
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Vz/F
时间窗: 30 days
Apparent Volume of Distribution (Vz/F) for VS-6766 administered with and without food.
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Tlag
时间窗: 30 days
absorption lag-time (Tlag)
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Kel
时间窗: 30 days
Elimination rate (Kel)
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: CL/F
时间窗: 30 days
Oral Clearance (CL/F)
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC%extrap
时间窗: 30 days
Area under plasma Concentration (AUC) extrapolated
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Cmax
时间窗: 30 days
Cmax for VS-6766 administered with and without food.
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Tmax
时间窗: 30 days
time of Maximum concentration (Tmax)
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-inf
时间窗: 30 days
Area under plasma Concentration (AUC) from zero to infinity
次要结局
- To assess the safety and tolerability of a single-dose of VS-6766 administered with or without a standardized high-fat/high-calorie meal in healthy adult subjects.(30 days)