A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Effects of Single Doses of NaV1.8 Inhibitors on C-Nociceptor Action Potentials in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Change From Baseline in Activity Dependent Slowing (ADS) Over Time
研究概览
简要总结
The purpose of this study is to determine the effects of Nav1.8 inhibition on activity-dependent slowing (ADS) of C-nociceptor nerve fibers, evoked action potential (AP) conduction velocity of C-nociceptor nerve fibers using VX-150, VX-993 and VX-548.
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
- Parallel
- 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 60 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 30.0 kilogram per meter square (kg/m^2)
- •A total body weight of more than (>) 50 kg
排除标准
- •History of febrile illness or other acute illness that has not fully resolved within 14 days before study drug dosing
- •Any condition possibly affecting drug absorption
- •Any dermatological (generalized) or autoimmune disease that may affect C-nociceptor excitability
- •Participants with Type 1 or Type 2 diabetes mellitus
- •Participants who have any 1 of the following criteria in the foot in which microneurography (MNG) will be performed:
- •Injection of local anesthetics or steroids within 35 days prior to randomization.
- •Unsuitable anatomy of the superficial peroneal nerve (i.e., nerve cannot be seen or palpated at the dorsum of the foot)
- •Infection, disease (dermatologic or vascular), ongoing pain, or recent trauma or surgery that may affect study assessments Note: Participants must have 1 foot that does not meet any of the above criteria to be eligible.
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
VX-150
Participants will be randomized to receive a single dose of VX-150.
干预措施: VX-150 (Drug)
VX-548
Participants will be randomized to receive a single dose of different dose levels of VX-548
干预措施: VX-548 (Drug)
VX-993
Participants will be randomized to receive a single dose of different dose levels of VX-993.
干预措施: VX-993 (Drug)
Placebo
Participants will receive single dose of non-matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Activity Dependent Slowing (ADS) Over Time
时间窗: From Pre-dose up to 2-hours Post Dose
次要结局
- Change From Baseline in Conduction Velocity at 0.25 Hz Over Time(From Pre-dose up to 2-hours Post Dose)
- Change From Baseline in Action Potential (AP) Latency at 0.25 Hz Over Time(From Pre-dose up to 2-hours Post Dose)
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)(From Day 1 up to Day 16)