A Microneurography Study of NaV1.8 Inhibition in Healthy Adults

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: VX-150; Drug: Placebo; Drug: VX-993; Drug: VX-548

• Registration Number: NCT06420765
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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.).

Study Timeline

• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-20
• Study Start: 2024-05-21
• Primary Completion: 2025-03-22
• Status Verified: 2025-04
• Study Completion: 2025-04-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VX-150	VX-150	Participants will be randomized to receive a single dose of VX-150.
Placebo	Placebo	Participants will receive single dose of non-matching placebo.
VX-993	VX-993	Participants will be randomized to receive a single dose of different dose levels of VX-993.
VX-548	VX-548	Participants will be randomized to receive a single dose of different dose levels of VX-548

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Activity Dependent Slowing (ADS) Over Time	From Pre-dose up to 2-hours Post Dose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

MAC Clinical Research; 🇬🇧 Manchester, United Kingdom