NCT06420765

A Microneurography Study of NaV1.8 Inhibition in Healthy Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	VX-150	Suspension for oral administration.
DRUG	VX-548	Solution or suspension for oral administration.
DRUG	VX-993	Suspension for oral administration.
DRUG	Placebo	Suspension for oral administration.

Timeline

• Start date: 2024-05-21
• Primary completion: 2025-03-22
• Completion: 2025-04-04
• First posted: 2024-05-20
• Last updated: 2025-04-20

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study