A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability of a Tablet Formulation of VX-581 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 16
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of VX-581
研究概览
简要总结
The purpose of this study is to evaluate the relative bioavailability of VX-581 tablet formulation compared to a suspension formulation along with its safety and tolerability.
详细描述
The purpose of this study is to evaluate the relative bioavailability of VX-581 tablet formulation compared to a suspension formulation along with its safety and tolerability in healthy human participants. Note: 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
- Male
- 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), inclusive
- •Total body weight of greater than (>) 50 kg
- •Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening
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
Sequence 1
Participants will be randomized to receive VX-581 suspension in dosing period 1 followed by VX-581 tablet in dosing period 2. A washout period of 10 days will be maintained between the 2 dosing periods.
干预措施: VX-581 (Drug)
Sequence 2
Participants will be randomized to receive VX-581 tablet in dosing period 1 followed by VX-581 suspension in dosing period 2. A washout period of 10 days will be maintained between the 2 dosing periods.
干预措施: VX-581 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of VX-581
时间窗: Period 1 and Period 2: From Day 1 up to Day 21
Area Under the Concentration Versus Time Curve (AUC) of VX-581
时间窗: Period 1 and Period 2: From Day 1 up to Day 21
次要结局
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 21))