A Microneurography Study of NaV1.8 Inhibition in Healthy Adults

Last updated: April 18, 2025
Sponsor: Vertex Pharmaceuticals Incorporated
Overall Status: Completed

Phase

1

Condition

Pain

Treatment

Placebo

VX-150

VX-548

Clinical Study ID

NCT06420765
VX23-PMI-001
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion

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-nociceptorexcitability

  • Participants with Type 1 or Type 2 diabetes mellitus

  • Participants who have any 1 of the following criteria in the foot in whichmicroneurography (MNG) will be performed:

  • Injection of local anesthetics or steroids within 35 days prior torandomization.

  • Unsuitable anatomy of the superficial peroneal nerve (i.e., nerve cannot beseen or palpated at the dorsum of the foot)

  • Infection, disease (dermatologic or vascular), ongoing pain, or recent traumaor surgery that may affect study assessments Note: Participants must have 1foot that does not meet any of the above criteria to be eligible.

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 92
Treatment Group(s): 4
Primary Treatment: Placebo
Phase: 1
Study Start date:
May 21, 2024
Estimated Completion Date:
April 04, 2025

Study 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.).

Connect with a study center

  • MAC Clinical Research

    Manchester,
    United Kingdom

    Site Not Available

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