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

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: VX-150

• Registration Number: NCT05418712
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

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.).

Study Timeline

• Study First Submitted: 2022-06-09
• Study First Submitted QC: 2022-06-09
• Study First Posted: 2022-06-14
• Study Start: 2022-06-16
• Primary Completion: 2022-09-14
• Study Completion: 2022-09-23
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-13
• Last Update Posted: 2022-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo matched to VX-150.
VX-150	VX-150	Participants will be randomized to receive a single dose of one of different dose levels VX-150.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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
Change From Baseline in Percentage Slowing Over Time	From Baseline up to 3 Hours After Dose	Percentage slowing is measured by a relative change in latency from the start to the end of each activity-dependent slowing (ADS) stimulus train.
Change From Baseline in Conduction Velocity at 0.25 Hz Over Time	From Baseline up to 3 Hours After Dose

Trial Locations

Locations (1)

MAC Clinical Research; 🇬🇧 Manchester, United Kingdom