A Microneurography Study of VX-150 in Healthy Subjects
Research type
Research Study
Full title
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating the Effects of VX-150 on C-Nociceptor Action Potentials in Healthy Subjects
IRAS ID
1005389
Contact name
Alexander Craft
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Eudract number
2022-000167-41
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to test a drug called VX-150 that is being developed for the treatment of pain. Pain is one of the most common symptoms for which patients seek medical attention. Current treatment options for pain are limited by poor effectiveness and high rates of side effects, leaving many patients without adequate pain management. Nonsteroidal anti inflammatory drugs (NSAIDs), e.g., aspirin and ibuprofen, are medicines that are widely used to relieve pain. Although NSAIDs are commonly used, they’re not suitable for everyone and can cause troublesome side effects. Opioids are medicines that are commonly prescribed for moderate to severe pain, e.g., codeine, tramadol and morphine, but their use is limited by safety issues, and they can become addictive. Given the limited treatment options, combined with the risks and ineffectiveness of current pain treatments, the development of new drugs for the treatment of pain with improved effectiveness and safety is vital for better pain management and health outcomes.\n\nApproximately 42 participants will be enrolled into this study, who will be divided into 4 groups. 3 groups will be administered different doses of VX-150 and 1 group will be administered a placebo. \n\nHealthy individuals aged 18 to 65 will be invited to take part. Participation in this study will last approximately 6 weeks and participants will be required to come for study visits on 3 occasions in total, consisting of a Screening visit and 2 outpatient visits. Participants will also be contacted by phone on 2 occasions. Study visits will take place at a Clinical Research Unit in the UK.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0139
Date of REC Opinion
15 Jun 2022
REC opinion
Further Information Favourable Opinion