Pain
Conditions
Brief summary
The purpose of this study is to determine the effects of Nav1.8 inhibition on activity-dependent slowing (ADS) of C-nociceptor nerve fibers, evoked action potential (AP) conduction velocity of C-nociceptor nerve fibers using VX-150, VX-993 and VX-548.
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.).
Interventions
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Activity Dependent Slowing (ADS) Over Time | From Pre-dose up to 2-hours Post Dose |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Conduction Velocity at 0.25 Hz Over Time | From Pre-dose up to 2-hours Post Dose |
| Change From Baseline in Action Potential (AP) Latency at 0.25 Hz Over Time | From Pre-dose up to 2-hours Post Dose |
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAE) | From Day 1 up to Day 16 |
Countries
United Kingdom
Outcome results
None listed