## Protocol Section
### Identification Module
**NCT ID:** NCT06420765

**Brief Title:** A Microneurography Study of NaV1.8 Inhibition in Healthy Adults

**Official Title:** A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Effects of Single Doses of NaV1.8 Inhibitors on C-Nociceptor Action Potentials in Healthy Adults

#### Organization Study ID Info
**ID:** VX23-PMI-001
#### Organization
**Class:** INDUSTRY
**Full Name:** Vertex Pharmaceuticals Incorporated
### Status Module
#### Completion Date
**Date:** 2025-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Vertex Pharmaceuticals Incorporated

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

### Description Module

**Brief Summary:** 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 and VX-548.

**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 Module

**Conditions:**

- Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: VX-150

**Label:** VX-150

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants will be randomized to receive a single dose of different dose levels of VX-548.

**Intervention Names:**

- Drug: VX-548

**Label:** VX-548

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants will receive single dose of non-matching placebo.

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- VX-150

**Description:** Suspension for oral administration.

**Name:** VX-150

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- VX-548

**Description:** Solution or suspension for oral administration.

**Name:** VX-548

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Placebo

**Description:** Suspension for oral administration.

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change From Baseline in Activity Dependent Slowing (ADS) Over Time

**Time Frame:** From Pre-dose up to 2-hours Post Dose

#### Secondary Outcomes

**Measure:** Change From Baseline in Conduction Velocity at 0.25 Hz Over Time

**Time Frame:** From Pre-dose up to 2-hours Post Dose

**Measure:** Change From Baseline in Action Potential (AP) Latency at 0.25 Hz Over Time

**Time Frame:** From Pre-dose up to 2-hours Post Dose

**Measure:** Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)

**Time Frame:** From Day 1 up to Day 16

### Eligibility Module

**Eligibility 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.

**Healthy Volunteers:** True

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** medicalinfo@vrtx.com

**Name:** Medical Information

**Phone:** 617-341-6777

**Role:** CONTACT

### IPD Sharing Statement Module

**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

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
