Clinical trial NCT05418712: A Microneurography (MNG) Study of VX-150 in Healthy Participants
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating the Effects of VX-150 on C-Nociceptor Action Potentials in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2022-06-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.).

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 \>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.

Primary outcomes:
measure: Change From Baseline in Action Potential (AP) Latency at 0.25 Hertz (Hz) Over Time
timeFrame: From Baseline up to 3 Hours After Dose
Secondary outcomes:
measure: Change From Baseline in Percentage Slowing Over Time
timeFrame: From Baseline up to 3 Hours After Dose
measure: 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
timeFrame: From Baseline up to 3 Hours After Dose
measure: 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
timeFrame: From Baseline up to 3 Hours After Dose
measure: Change From Baseline in Conduction Velocity at 0.25 Hz Over Time
timeFrame: From Baseline up to 3 Hours After Dose
measure: Change From Baseline in AP Amplitude at 0.25 Hz Over Time
timeFrame: From Baseline up to 3 Hours After Dose
measure: Change From Baseline in the Area Under the AP Peaks at 0.25 Hz Over Time
timeFrame: From Baseline up to 3 Hours After Dose
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE)
timeFrame: Day 1 up to Day 10
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: MAC Clinical Research
Study officials:
References: