A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Effects of Single Doses of NaV1.8 Inhibitors on C-Nociceptor Action Potentials in Healthy Adults

VX23-PMI-001

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 and VX-548.

2024-05-01

2025-09-01

2025-09-01

Not yet recruiting

Early phase I

40

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-05-20