Testing VX-581 for safety in healthy adults and people with cystic fibrosis
Tests VX-581 for safety in healthy adults and adults with cystic fibrosis.
Plain-language title generated from the registry record
Registry title: Evaluation of VX-581 in Healthy Participants and in Participants With Cystic Fibrosis
Key facts
- Where
- Overland Park, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT07283770, who can take part
Where in United States
- Altasciences - Kansas CityOverland Park, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vertex Pharmaceuticals Incorporated
- Trial code
- NCT07283770
- Record updated
- 19 October 2026
- Original description
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single dose of VX-581 and multiple ascending doses of VX-581 alone and in combination with tezacaftor (TEZ)/deutivacaftor (D-IVA) or D-IVA in healthy participants. The study will also evaluate the safety, tolerability, and pharmacokinetics of VX-581 administered in combination with D-IVA with or without TEZ in participants with cystic fibrosis (CF).Read full original descriptionShow less
A Phase 1 Study of VX-581 in Healthy Subjects and in Subjects With Cystic Fibrosis
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single dose of VX-581 and multiple ascending doses of VX-581 alone and in combination with tezacaftor (TEZ)/deutivacaftor (D-IVA) or D-IVA in healthy participants. The study will also evaluate the safety, tolerability, and pharmacokinetics of VX-581 administered in combination with D-IVA with or without TEZ in participants with cystic fibrosis (CF).
Inclusion: Parts A, B, C:; 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; Part D:; Confirmed diagnosis of CF.
Exclusion: Parts A, B, C:; 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; Part D:; History of clinically significant cirrhosis with or without portal hypertension; Other protocol defined Inclusion/Exclusion criteria may apply.