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Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-581 in Healthy Subjects
Who can join
Ages 18 to 55 · All sexes · Healthy volunteers welcome
Full eligibility 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 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.
About the study
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 for up to ten days.
What is being tested
- VX-581 (drug)
- Placebo (drug)
- D-IVA (drug)
- TEZ (drug)
Sponsor: Vertex Pharmaceuticals Incorporated · Participants: 136 · Started: Dec 9, 2025
Contact the study team
- Medical Information · Phone: 617-341-6777
Official record on ClinicalTrials.gov — NCT07283770
Locations in the U.S.
| Kansas | Altasciences - Kansas City, Overland Park |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.