A Microneurography Study of NaV1.8 Inhibition in Healthy Adults

Launched by VERTEX PHARMACEUTICALS INCORPORATED · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a specific type of nerve blocker, called NaV1.8 inhibitors, affects pain signals in healthy adults. The researchers want to see how these blockers influence the way certain nerve fibers, known as C-nociceptors, respond to pain. They will use three different medications (VX-150, VX-993, and VX-548) to understand their effects on nerve signals.

To participate, you need to be between the ages of 18 and 65, have a body weight of more than 50 kg, and a body mass index (BMI) between 18.0 and 30.0. However, if you have certain health conditions, such as diabetes or a recent illness, you might not qualify. If you decide to join, you can expect to undergo tests that measure how your nerves react to pain and how well the medications work. This study is important because it could help improve pain management treatments in the future.

Gender

ALL

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.