Dose escalation of VX-581 to check safety and drug levels in healthy adults
Official title: A Phase 1 Study of VX-581 in Healthy Subjects and in Subjects With Cystic Fibrosis
Run by Vertex Pharmaceuticals Incorporated · NCT07283770 · Data updated 2026-11-12
The trial will test increasing doses of VX-581 in healthy adults to see if it is safe and to measure how the body absorbs and clears the drug.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 152 (estimated) |
| Sponsor | Vertex Pharmaceuticals Incorporated Industry-sponsored |
| Locations | 1 site (Overland Park, Kansas) |
| Status | Recruiting |
| Started | December 9, 2025 |
| Main results expected | July 12, 2027 |
| Study ends | July 12, 2027 |
| Registry record updated | October 19, 2026 |
| Trial ID | NCT07283770 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adults with BMI 18–32 kg/m2, body weight over 50 kg, and who are of non-childbearing potential.
✕Probably not a fit
People with unresolved recent febrile or acute illness, conditions that affect drug absorption, those of childbearing potential, or patients expecting direct therapeutic benefit (e.g., people with cystic fibrosis) are unlikely to receive clinical benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1, randomized, placebo-controlled study administers single and multiple ascending doses of VX-581 to healthy adults to characterize safety, tolerability, and pharmacokinetics. Participants go through a screening phase, a treatment phase with scheduled dosing, and a safety follow-up visit. Safety monitoring includes vital signs, laboratory tests, and adverse event reporting, while serial blood sampling measures drug concentrations over time. Enrollment criteria include BMI 18–32 kg/m2, body weight >50 kg, and participants must be of non-childbearing potential.
Why it matters
Potential benefit: If successful, the results will define safe dose ranges and how the drug behaves in the body to guide further development of VX-581 for cystic fibrosis.
How similar studies have gone: Early-phase single- and multiple-ascending-dose safety and PK studies are standard and have supported development of other cystic fibrosis therapies, but VX-581 itself has not yet been shown to be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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.
Where it's running
-
Altasciences - Kansas City
Overland Park, Kansas, United States Recruiting
Study contacts
- Study coordinator: Medical Information
- Email: medicalinfo@vrtx.com
- Phone: 617-341-6777
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.