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

NCT05418712 | Completed Phase 1 FDA Drug

• 1 other identifier: VX22-150-012
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Action Potential (AP) Latency at 0.25 Hertz (Hz) Over Time

  From Baseline up to 3 Hours After Dose

Secondary Outcomes (7)

• Change From Baseline in Percentage Slowing Over Time

  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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to VX-150.

Drug: Placebo

VX-150

EXPERIMENTAL

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

Drug: VX-150

Interventions

Placebo DRUG

Placebo matched to VX-150 for oral administration.

Placebo

VX-150 DRUG

Solution or Suspension for oral administration.

VX-150

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m\^2)
• A total body weight \>50 kg

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

MAC Clinical Research

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 14, 2022
• Study Start: June 16, 2022
• Primary Completion: September 14, 2022
• Study Completion: September 23, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)