Testing VX-973 for safety and effects in healthy people
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose Escalation Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of VX-973 in Healthy Adults
This study is testing a new drug called VX-973 in healthy people to see if it's safe and how it works, which could help in future treatments for pain.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Vertex Pharmaceuticals Incorporated Industry-sponsored |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT06615570 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of VX-973 through single and multiple doses administered to healthy participants. The study is designed as a Phase 1 dose escalation trial, meaning that doses will gradually increase to determine the highest dose that can be given safely. Participants will receive either the VX-973 drug or a placebo to assess the drug's effects compared to no treatment. The trial aims to gather important data that could inform future studies in patients with pain.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults with a BMI between 18.0 and 32.0 kg/m² and a body weight greater than 50 kg.
Not a fit: Patients with acute illnesses or conditions affecting drug metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of VX-973's safety profile and its potential effectiveness in treating pain.
How similar studies have performed: Other studies have shown success with similar dose escalation approaches in early-phase trials, but the specific drug VX-973 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * A total body weight of more than (\>) 50 kg * Participants of non-childbearing potential * Nonsmoker or ex-smoker for at least 3 months before screening Key Exclusion Criteria: * History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * Any condition possibly affecting drug absorption, distribution, metabolism, or excretion Other protocol defined Inclusion/Exclusion criteria may apply.
Where this trial is running
Salt Lake City, Utah
- ICON Salt Lake City — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Medical Information
- Email: medicalinfo@vrtx.com
- Phone: 617-341-6777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.