Clinical trial NCT06420765: A Microneurography Study of NaV1.8 Inhibition in Healthy Adults
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2024-05-20
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.).

Eligibility criteria: Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline in Activity Dependent Slowing (ADS) Over Time
timeFrame: From Pre-dose up to 2-hours Post Dose
Secondary outcomes:
measure: Change From Baseline in Conduction Velocity at 0.25 Hz Over Time
timeFrame: From Pre-dose up to 2-hours Post Dose
measure: Change From Baseline in Action Potential (AP) Latency at 0.25 Hz Over Time
timeFrame: From Pre-dose up to 2-hours Post Dose
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)
timeFrame: From Day 1 up to Day 16
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: MAC Clinical Research
Study officials:
References: