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

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

Detailed Description
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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.).

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Placebo
* Drug: VX-150


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |