A Microneurography Study of NaV1.8 Inhibition in Healthy Adults

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: VX-993; Drug: Placebo; Drug: VX-548; Drug: VX-150

Study type: Interventional

Funder types: Industry

Identifiers

NCT06420765

VX23-PMI-001

Details and patient eligibility

About

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.

Full 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.).

Enrollment: 92 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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92 participants in 4 patient groups, including a placebo group

VX-150

Experimental group

Description:

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

Treatment:

Drug: VX-150

VX-548

Experimental group

Description:

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

Treatment:

Drug: VX-548

VX-993

Experimental group

Description:

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

Treatment:

Drug: VX-993

Placebo

Placebo Comparator group

Description:

Participants will receive single dose of non-matching placebo.

Treatment:

Drug: Placebo