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Completed

NCT Number: NCT06420765

A Microneurography Study of NaV1.8 Inhibition in Healthy Adults

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MAC Clinical Research

Manchester, United Kingdom

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VX-150

Drug

Suspension for oral administration.

VX-548

Drug

Solution or suspension for oral administration.

VX-993

Drug

Suspension for oral administration.

Placebo

Drug

Suspension for oral administration.

Primary outcomes

  1. Change From Baseline in Activity Dependent Slowing (ADS) Over Time

    Time frame: From Pre-dose up to 2-hours Post Dose

Secondary outcomes

  1. Change From Baseline in Conduction Velocity at 0.25 Hz Over Time

    Time frame: From Pre-dose up to 2-hours Post Dose

  2. Change From Baseline in Action Potential (AP) Latency at 0.25 Hz Over Time

    Time frame: From Pre-dose up to 2-hours Post Dose

  3. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)

    Time frame: From Day 1 up to Day 16

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 20, 2024
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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