A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Cystic Fibrosis
In brief
This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects. Parts D, E, and F were conducted in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).
Key facts
- Study ID
- NCT03227471
- Run by
- Vertex Pharmaceuticals Incorporated
- People needed
- 225
- Starts
- 2017-01-23
- Expected to finish
- 2018-03-27
- Last updated by the study team
- 2022-01-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Banner University of Arizona Medical Center — Tucson, Arizona, United States
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Valley Children's Healthcare — Madera, California, United States
- (Kaiser Permanente) Oakland Medical Center — Oakland, California, United States
- National Jewish Health — Denver, Colorado, United States
- Central Florida Pulmonary Group — Orlando, Florida, United States
- Tampa General Hospital Cardiac and Lung Transplant Clinic — Tampa, Florida, United States
- Children's Specialty Services at North Druid Hills — Atlanta, Georgia, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Covance Clinical Research Unit Inc., Evansville Clinic [Parts A, B, C only] — Evansville, Indiana, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- Tulane Medical Center — New Orleans, Louisiana, United States
- Harper University Hospital — Detroit, Michigan, United States
- Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minn — Minneapolis, Minnesota, United States
- Morristown Medical Center — Morristown, New Jersey, United States
- University of New Mexico School of Medicine — Albuquerque, New Mexico, United States
- UC Health Office of Clinical Research — Cincinnati, Ohio, United States
- University Hospitals Cleveland Medical Center/Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Austin Children's Chest Associates — Austin, Texas, United States
- The University of Vermont — Burlington, Vermont, United States
- University of Virginia Health System — Charlottesville, Virginia, United States
- West Virginia University Hospitals — Morgantown, Virginia, United States
- Children's Hospital of the King's Daughters — Norfolk, Virginia, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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