A Microneurography Study of NaV1.8 Inhibition in Healthy Adults

NCT ID: NCT06420765

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-21
• Study Completion Date: 2025-04-04

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.).

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

VX-150

Participants will be randomized to receive a single dose of VX-150.

Group Type: EXPERIMENTAL

VX-150

Intervention Type: DRUG

Suspension for oral administration.

VX-548

Participants will be randomized to receive a single dose of different dose levels of VX-548

Group Type: EXPERIMENTAL

VX-548

Intervention Type: DRUG

Solution or suspension for oral administration.

VX-993

Participants will be randomized to receive a single dose of different dose levels of VX-993.

Group Type: EXPERIMENTAL

VX-993

Intervention Type: DRUG

Suspension for oral administration.

Placebo

Participants will receive single dose of non-matching placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Suspension for oral administration.

Interventions

VX-150

Suspension for oral administration.

Intervention Type: DRUG

VX-548

Solution or suspension for oral administration.

Intervention Type: DRUG

VX-993

Suspension for oral administration.

Intervention Type: DRUG

Placebo

Suspension for oral administration.

Intervention Type: DRUG

Eligibility Criteria

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MAC Clinical Research

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

VX23-PMI-001

Identifier Type: -

Identifier Source: org_study_id