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Completed

NCT Number: NCT05418712

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MAC Clinical Research

Manchester, United Kingdom

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Placebo matched to VX-150 for oral administration.

VX-150

Drug

Solution or Suspension for oral administration.

Primary outcomes

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

    Time frame: From Baseline up to 3 Hours After Dose

Secondary outcomes

  1. Change From Baseline in Percentage Slowing Over Time

    Time frame: 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.

  2. 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

    Time frame: From Baseline up to 3 Hours After Dose

  3. 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

    Time frame: From Baseline up to 3 Hours After Dose

  4. Change From Baseline in Conduction Velocity at 0.25 Hz Over Time

    Time frame: From Baseline up to 3 Hours After Dose

  5. Change From Baseline in AP Amplitude at 0.25 Hz Over Time

    Time frame: From Baseline up to 3 Hours After Dose

  6. Change From Baseline in the Area Under the AP Peaks at 0.25 Hz Over Time

    Time frame: From Baseline up to 3 Hours After Dose

  7. Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)

    Time frame: Day 1 up to Day 10

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2022
Registry last updated
Oct 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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