VX-993 for Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the body processes a new pain treatment, 14C-VX-993, after oral administration. Researchers aim to understand how the body absorbs, metabolizes, and eliminates this treatment. They seek participants who weigh more than 50 kg, have a BMI between 18 and 32, and experience at least one regular bowel movement daily. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that VX-993 was generally safe and well tolerated in earlier studies. Most side effects were mild to moderate, indicating they weren't severe. No serious safety issues emerged, suggesting the treatment is likely safe based on past research. However, as this is a Phase 1 trial, the study remains in the early stages. This phase primarily examines how the body handles the drug, including its safety and how the body absorbs, distributes, and eliminates it.12345
Why do researchers think this study treatment might be promising?
Unlike the standard pain relief options such as NSAIDs, opioids, and acetaminophen, 14C-VX-993 is unique because it introduces a novel active ingredient with a potentially new mechanism of action. Researchers are excited about this treatment as it could offer an alternative pathway for pain management, possibly reducing the reliance on traditional painkillers that often come with significant side effects or risk of dependency. Additionally, the single oral dose administration after fasting may improve patient compliance and streamline the treatment process, making it a promising candidate for future pain management strategies.
What evidence suggests that 14C-VX-993 might be an effective treatment for pain?
Research has shown that VX-993 has not been effective in treating sudden pain. In earlier studies, VX-993 did not outperform current pain treatments or even a placebo, which contains no active medicine. The drug targets a protein called NaV1.8, involved in sending pain signals, but it did not reduce pain more effectively than common painkillers like hydrocodone. Due to these results, the development of VX-993 for sudden pain was halted. In this trial, participants will receive a single oral dose of 14C-VX-993 to study how the body processes the drug, but its ability to relieve pain remains unproven.23678
Are You a Good Fit for This Trial?
This trial is for individuals over 50 kg with a BMI of 18.0 to 32.0 who have at least one regular bowel movement daily. It's not specified who can't join, but typically those with health conditions affecting drug processing or conflicting medications would be excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of 14C-VX-993 after an overnight fast
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 14C-VX-993
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vertex Pharmaceuticals Incorporated
Lead Sponsor
Dr. David Altshuler
Vertex Pharmaceuticals Incorporated
Chief Medical Officer since 2020
MD, PhD
Dr. Reshma Kewalramani
Vertex Pharmaceuticals Incorporated
Chief Executive Officer since 2020
MD, trained in internal medicine and nephrology