A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of Suzetrigine in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Part B: AUC0-tlast of SUZ
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (PK) of suzetrigine (SUZ; VX-548) and its metabolite along with its safety and tolerability, in healthy participants.
详细描述
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
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
- •Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m^2)
- •A total body weight greater than (>) 50 kilogram (kg)
- •Participants of non-childbearing potential
排除标准
- •History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
- •Any condition possibly affecting drug absorption
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Part B
Participants will be randomized to receive a single dose of SUZ formulation in 1 of 2 treatment sequences with 2 dosing periods to assess the relative bioavailability of tablet formulation compared to a suspension of SUZ. There will be a 14-day washout period between each dosing period.
干预措施: Suzetrigine (Drug)
Part A
Participants will be randomized to receive a single dose of SUZ in 1 of 6 treatment sequences with 3 dosing periods to assess the relative bioavailability of two tablet formulations and the effect of food on the PK of SUZ. There will be a 14-day washout period between each dosing period.
干预措施: Suzetrigine (Drug)
结局指标
主要结局
Part B: AUC0-tlast of SUZ
时间窗: Pre-dose up to Day 29
Part A: Maximum Observed Plasma Concentration (Cmax) of SUZ
时间窗: Pre-dose up to Day 43
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of SUZ
时间窗: Pre-dose up to Day 43
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of SUZ
时间窗: Pre-dose up to Day 43
Part B: Cmax of SUZ
时间窗: Pre-dose up to Day 29
Part B: AUC0-inf of SUZ
时间窗: Pre-dose up to Day 29
次要结局
- Part B: Cmax of SUZ Metabolite(Pre-dose up to Day 29)
- Part A: Cmax of SUZ Metabolite(Pre-dose up to Day 43)
- Part A: AUC0-inf of SUZ Metabolite(Pre-dose up to Day 43)
- Part A: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 43)
- Part B: AUC0-inf of SUZ Metabolite(Pre-dose up to Day 29)
- Part B: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs(From Day 1 up to Day 29)
- Part A: AUC0-tlast of SUZ Metabolite(Pre-dose up to Day 43)
- Part B: AUC0-tlast of SUZ Metabolite(Pre-dose up to Day 29)