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Evaluation of VX-581 in Healthy Participants and in Participants With Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
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 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).
Official title: A Phase 1 Study of VX-581 in Healthy Subjects and in Subjects With Cystic Fibrosis
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
152
Start Date
2025-12-09
Completion Date
2027-07-12
Last Updated
2026-10-19
Healthy Volunteers
Yes
Conditions
Interventions
VX-581
Suspension for Oral Administration.
Placebo
Suspension for Oral Administration.
D-IVA
Tablet for Oral Administration.
TEZ
Tablet for Oral Administration.
ELX/TEZ/IVA
Fixed dose combination (FDC) Tablets for Oral Administration.
VX-581
Tablets for Oral Administration.
IVA
Tablet for Oral Administration.
Locations (1)
Altasciences - Kansas City
Overland Park, Kansas, United States