Clinical Trial

Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants

Recruiting Phase 1
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Summary
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.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-07-17
minor Trial arms changed: 4 -> 6 2026-07-17
Trial Details
NCT Number NCT07283770
Lead Sponsor Vertex Pharmaceuticals Incorporated
Conditions Cystic Fibrosis
Enrollment 136 participants
Start Date 2025-12-09
Primary Completion 2026-11-19 (estimated)
Study Completion 2026-11-19 (estimated)
Updated on ClinicalTrials.gov 2026-07-16