Dose escalation of VX-581 to check safety and drug levels in healthy adults
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-581 in Healthy Subjects
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 |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Vertex Pharmaceuticals Incorporated Industry-sponsored |
| Locations | 1 site (Overland Park, Kansas) |
| Trial ID | NCT07283770 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
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 * Male and Female participants of non-childbearing potential 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 Other protocol defined Inclusion/Exclusion criteria may apply.
Where this trial is running
Overland Park, Kansas
- Altasciences - Kansas City — Overland Park, Kansas, 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.