A Microneurography (MNG) Study of VX-150 in Healthy Participants

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: Placebo; Drug: VX-150

Study type: Interventional

Funder types: Industry

Identifiers

NCT05418712

VX22-150-012

Details and patient eligibility

About

The purpose of this study is to determine if C fiber conduction is impacted by NAV1.8 modulation.

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: 45 patients

Sex: All

Ages: 18 to 65 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 >50 kg

Key Exclusion Criteria:

• Participants who have any 1 of the following criteria in the foot/ankle in which 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/ankle)
  • Infection, disease (dermatologic or vascular), ongoing pain, or recent trauma or surgery that may affect study assessments

• History of febrile illness within 14 days before study drug dosing

• Any condition possibly affecting drug absorption

• Participants with Type 1 or Type 2 diabetes mellitus

• Any dermatological (generalized) or autoimmune disease that may affect C-nociceptor excitability

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to VX-150.

Treatment:

Drug: Placebo

VX-150

Experimental group

Description:

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

Treatment:

Drug: VX-150