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

NCT ID: NCT05418712

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-16
• Study Completion Date: 2022-09-23

Brief Summary

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Participants will receive placebo matched to VX-150.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matched to VX-150 for oral administration.

VX-150

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

Group Type: EXPERIMENTAL

VX-150

Intervention Type: DRUG

Solution or Suspension for oral administration.

Interventions

Placebo

Placebo matched to VX-150 for oral administration.

Intervention Type: DRUG

VX-150

Solution or Suspension for oral administration.

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MAC Clinical Research

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

VX22-150-012

Identifier Type: -

Identifier Source: org_study_id