Purpose of the NAVIGATE-1 Study

The NAVIGATE-1 Study is evaluating the safety and effectiveness of an investigational study drug, called VX-548, in people experiencing acute pain after a bunion repair procedure. This clinical research study is part of the Vertex pain research program, which is developing medicines aimed at selectively targeting the underlying cause of the pain response.

Who May Qualify

Eligible participants must:

  • Be 18 to 80 years of age (inclusive)
  • Not have a prior history of bunion repair surgery or other foot surgery on the index foot or bunion repair surgery on the opposite foot as part of this study or prior Vertex study
  • Be willing and able to comply with study instructions

There are additional eligibility requirements, which the study doctor can explain to you.

Study Participation

Participation in the NAVIGATE-1 Study will last approximately six weeks. During this time, participants will visit the study site once for their bunion repair procedure and may have up to two clinic visits or remote visits.

Screening period

Can be up to four weeks (with a one-week extension in some cases) and usually consists of one visit. This visit has the option of being conducted at home. The purpose of this period is to evaluate all interested individuals to see if they meet the eligibility requirements.

Treatment period

Lasts approximately four days. Participants will be admitted to the clinical research unit one day before their bunion repair procedure and will remain in the clinical research unit until at least 48 hours after the procedure. During this period, participants will take their assigned study treatment every six hours. The study team will monitor the participants’ health and pain levels throughout this period.

Safety follow-up visit

This visit takes place approximately 14 days after the last dose of study drug. It may be conducted at the clinic or through a home health visit. The purpose of this visit is for the study team to check on participants’ health after they stop taking the study drug and to ensure the surgical wound is healing properly.

About the Study Drug

Researchers are investigating the safety and effectiveness of the investigational study drug, VX-548, in adults with acute pain post–bunion repair. VX-548 is intended to block one of the channels that plays a critical role in signaling pain to the nervous system. An investigational study drug is a medication that is not yet approved for use by the Food and Drug Administration (FDA) in the United States or other regulatory agencies in Canada, Europe, or elsewhere.

There are three treatment groups in this study, with one group receiving VX-548, one group receiving a comparator drug (an FDA-approved treatment for pain: hydrocodone bitartrate combined with acetaminophen), and one group receiving a placebo (a substance that looks like the study drug but contains no active ingredients). The use of a placebo in this study will help the researchers by providing a baseline to compare the study drug to. Each participant will be assigned randomly to one of the groups and will take oral tablets or capsules of their assigned study treatment every six hours with water. During the study, neither the participant nor the study doctor will know which group they are in, but in case of emergency, the study doctor can quickly find out.

See If You May Qualify