A Microneurography Study of NaV1.8 Inhibition in Healthy Adults

NCT06420765 | Completed Phase 1 FDA Drug

• 1 other identifier: VX23-PMI-001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

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

  From Pre-dose up to 2-hours Post Dose

Secondary Outcomes (3)

• 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

Study Arms (4)

VX-150

EXPERIMENTAL

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

Drug: VX-150

VX-548

EXPERIMENTAL

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

Drug: VX-548

VX-993

EXPERIMENTAL

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

Drug: VX-993

Placebo

PLACEBO COMPARATOR

Participants will receive single dose of non-matching placebo.

Drug: Placebo

Interventions

VX-150 DRUG

Suspension for oral administration.

VX-150

VX-548 DRUG

Solution or suspension for oral administration.

VX-548

VX-993 DRUG

Suspension for oral administration.

VX-993

Placebo DRUG

Suspension for oral administration.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

MAC Clinical Research

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: May 21, 2024
• Primary Completion: March 22, 2025
• Study Completion: April 4, 2025
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)