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The Role of NaV1.8 in Human Pain Models

NCT07511400 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-04-30

No results posted yet for this study

Summary

This study aims to understand how NaV1.8, a specific type of sodium channel found in peripheral nerves, contributes to different types of pain in humans. To address this, suzetrigine, a highly selective blocker of the NaV1.8 channel, is used. While current pain medications often have side effects that limit their use, NaV1.8 is a promising target for new, non-opioid pain treatments because it is primarily located in the nerves that send pain signals to the brain.

This study is a randomised, placebo-controlled double-blind crossover microdosing trial. This means that very small, safe amounts of the drug are injected directly into the skin of healthy volunteers to observe its effects locally. This approach ensures the drug works only at the injection site with negligible exposure to the rest of the body.

Healthy volunteers will undergo six different types of brief, controlled pain tests to see which ones are reduced by blocking NaV1.8.

These tests are as follows:

* Electrical stimulation: Brief electrical pulses delivered onto the skin.
* Mechanical stimulation: A standardised "pin-prick" stimulation of the skin.
* Chemical stimulation: An injection of fluid containing capsaicin (the active component of chilli peppers) superficially into the skin.
* Heat stimulation: An injection of hot fluid superficially into the skin.
* Cold stimulation: An injection of cold fluid superficially into the skin.
* Acid stimulation: An injection of acidic fluid superficially into the skin.

By comparing the effects of suzetrigine against a placebo and a standard local anaesthetic (lidocaine), the study will help determine which specific pain modalities critically depend on NaV1.8.

Conditions

  • Pain
  • Acute Pain
  • Healthy Volunteer Study

Interventions

DRUG

Suzetrigine

A selective NaV1.8 inhibitor. It is administered at a concentration of 1 µM via intracutaneous injection at the site of pain induction. The total dose per subject is 1.53 µg.

DRUG

Lidocaine (drug)

A non-selective NaV inhibitor. It is administered at a concentration of 2 mM via intracutaneous injection at the site of pain induction. The total dose per subject is 120 µg.

DRUG

Control Solution

A control solution mimicking extracellular fluid. It is administered via intracutaneous injection at the site of pain induction.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Michael J.M. Fischer, Professor · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-21
Primary Completion
2026-10-12
Completion
2026-10-12
FDA Drug
Yes

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07511400 on ClinicalTrials.gov