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

A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating the Effects of VX-150 on C-Nociceptor Action Potentials in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: VX-150

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.).

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • MAC Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive placebo matched to VX-150.	Drug: Placebo; Placebo matched to VX-150 for oral administration.
Experimental: VX-150; Participants will be randomized to receive a single dose of one of different dose levels VX-150.	Drug: VX-150; Solution or Suspension for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Action Potential (AP) Latency at 0.25 Hertz (Hz) Over Time	From Baseline up to 3 Hours After Dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Percentage Slowing Over Time	Percentage slowing is measured by a relative change in latency from the start to the end of each activity-dependent slowing (ADS) stimulus train.	From Baseline up to 3 Hours After Dose
Change From Baseline in the Time to Reverse 50 Percent (%) of the Activity-induced Latency Change After the End of Each ADS Stimulus Train Over Time		From Baseline up to 3 Hours After Dose
Change From Baseline in the Percentage Recovery of the Activity-induced Latency Change at 30 Seconds After the End of Each ADS Stimulus Train Over Time		From Baseline up to 3 Hours After Dose
Change From Baseline in Conduction Velocity at 0.25 Hz Over Time		From Baseline up to 3 Hours After Dose
Change From Baseline in AP Amplitude at 0.25 Hz Over Time		From Baseline up to 3 Hours After Dose
Change From Baseline in the Area Under the AP Peaks at 0.25 Hz Over Time		From Baseline up to 3 Hours After Dose
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)		Day 1 up to Day 10

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2022
• Primary Completion (Actual): September 14, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: VX22-150-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No