NCT07283770RecruitingPhase 1
Evaluation of VX-581 in Healthy Participants and in Participants With Cystic Fibrosis
A Phase 1 Study of VX-581 in Healthy Subjects and in Subjects With Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 152 (estimated)
- First submitted
- 4 Dec 2025
- Start date
- 9 Dec 2025
- Primary completion date
- 12 Jul 2027
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Diseases
- Cystic fibrosis
- NCT number
- NCT07283770
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 152
- From 9 Dec 2025 to the primary completion date, 12 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Part D:
- History of clinically significant cirrhosis with or without portal hypertension.
- Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Altasciences - Kansas City Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.