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Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Summary
The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics of VX-828 and VX-828 in triple combination (TC) with Tezacaftor (TEZ)/ VX-118 or TEZ/ deutivacaftor (D-IVA) in healthy participants and VX-828 in combination with D-IVA with or without TEZ in participants with cystic fibrosis (CF).
Official title: A Phase 1, Study of VX-828 in Healthy Subjects and in Subjects With Cystic Fibrosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
255
Start Date
2023-12-12
Completion Date
2026-04-23
Last Updated
2026-03-27
Healthy Volunteers
Yes
Conditions
Interventions
VX-828
Suspension for Oral Administration
Placebo
Suspension for Oral Administration
Itraconazole
Solution for Oral Administration
Midazolam
Syrup for Oral Administration
Tezacaftor
Tablets for Oral Administration
VX-118
Tablets for Oral Administration
Placebo
Suspension and Tablets for Oral Administration
Deutivacaftor
Tablets for Oral Administration
VX-828
Tablets for Oral Administration
Locations (11)
Joe DiMaggio Cycstic Fibrosis & Pulmonary Center
Hollywood, Florida, United States
Central Florida Pulmonary Group, P.A.
Orlando, Florida, United States
Altasciences Clinical Kansas
Overland Park, Kansas, United States
Kentucky Children's Hospital
Lexington, Kentucky, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Minnesota -Pulmonology
Minneapolis, Minnesota, United States
New York Medical College
Hawthorne, New York, United States
ProMedica Toledo Children's Hospital & ProMedica Central Physicians, LLC
Toledo, Ohio, United States
Cook Children's Pulmonology
Fort Worth, Texas, United States
University of Utah Hospital - Pulmonology
Salt Lake City, Utah, United States
Vermont Lung Center
Colchester, Vermont, United States