Phase 1 Single Doses of NaV1.8 Inhibitors on C Nociceptor Action Potentials in Healthy Adults
Research type
Research Study
Full title
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
IRAS ID
1009556
Contact name
Toluwalope Cole
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Research summary
This is a phase 1 randomised, double-blind, placebo-controlled study to find out how the investigational drugs, VX-548 and VX-150, impact the nerve signals involved in pain under regular conditions in healthy participants, in the absence of pain.
Pain is one of the most common symptoms for which people seek medical attention and many of the current available treatments have a lot of side-effects or are likely to be abused. Both VX-548 and VX-150 act on the voltage-gated sodium channel 1.8 (NaV1.8) in nerves, which plays an important role in transmission of pain signals. It is thought that a drug that targets this mechanism will result in fewer side effects compared to traditional painkillers and is less likely to become a substance of abuse.
Participants will be assigned randomly to 1 of 4 treatment groups, 3 with active Study Drug and 1 with placebo (looks like active Study Drug but has no effect). A participant has an equal chance of being assigned to any of the treatment groups meaning they have a 75% chance of being administered the active study drug and 25% chance of being administered placebo. Neither the participant nor the clinical staff will know which treatment group the participant is assigned to.The study includes a screening period that will last up to 26 days, a study treatment period that will last up to 6 days and a safety follow-up period that will last up to 11 days. The total study duration will be approximately 6 weeks.
Assessments include physical examinations, vital signs, electrocardiograms (ECGs), blood and urine sample collection for testing and Microneurography, which is a technique that requires thin needles, that contain electrodes, to be inserted under the skin on the top of the participant’s foot in order to measure the function of a nerve there.
Approximately 40 healthy adults, male and female aged 18 to 60 years old, will participate in this study in 1 site in the UK. The sponsor of this trial is Vertex Pharmaceuticals Inc.REC name
Wales REC 1
REC reference
24/WA/0037
Date of REC Opinion
11 Apr 2024
REC opinion
Further Information Favourable Opinion