A Microneurography Study of NaV1.8 Inhibition in Healthy Adults

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06420765
• Other study ID #: VX23-PMI-001
• Status: Recruiting
• Phase: Phase 1
• Start date: May 21, 2024
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Vertex Pharmaceuticals Incorporated
• Contact: Medical Information
• Phone: 617-341-6777
• Email: medicalinfo[@]vrtx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and VX-548.

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.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• VX-150
Suspension for oral administration.
• VX-548
Solution or suspension for oral administration.
• Placebo
Suspension for oral administration.

Locations

Country	Name	City	State
United Kingdom	MAC Clinical Research	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Activity Dependent Slowing (ADS) Over Time		From Pre-dose up to 2-hours Post Dose
Secondary	Change From Baseline in Conduction Velocity at 0.25 Hz Over Time		From Pre-dose up to 2-hours Post Dose
Secondary	Change From Baseline in Action Potential (AP) Latency at 0.25 Hz Over Time		From Pre-dose up to 2-hours Post Dose
Secondary	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