Study of VX-809 in Cystic Fibrosis Subjects With the ∆F508-CFTR Gene Mutation

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

The primary objective of the study was to evaluate the safety and tolerability of VX-809 in participants with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

Key facts

Study ID

NCT00865904

Run by

Vertex Pharmaceuticals Incorporated

People needed

93

Starts

2009-03-01

Expected to finish

2009-12-01

Last updated by the study team

2015-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of CF with ∆F508-CFTR mutation in both alleles
• Forced expiratory volume in 1 second (FEV1) greater than or equal to (>=) 40 percent (%) of predicted normal for age, gender, and height
• Weight >=40 kilograms (kg) and body mass index greater than or equal to 18.5 kilogram per square meter (kg/m\^2)
• Screening laboratory values, tests, and physical examination within acceptable ranges
• Negative pregnancy test (for women of child-bearing potential)
• Able and willing to follow contraceptive requirements
• Willing to remain on a stable medication regimen for the duration of study participation

You may not qualify if…

• History of any illness, or any ongoing acute illness, that could impact the safety of the study participant or may confound results of study
• Pulmonary exacerbation or changes in therapy for pulmonary disease within 14 days before receiving the first dose of study drug
• Impaired hepatic or renal function
• History of organ or hematological transplant

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Palo Alto, California, United States
• Study site — San Diego, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Seattle, Washington, United States
• Study site — Brussels, Belgium
• Study site — Leuven, Belgium
• Study site — Toronto, Ontario, Canada
• Study site — Cologne, Germany
• Study site — Hanover, Germany
• Study site — Rotterdam, Netherlands
• Study site — Utrecht, Netherlands

Full record on ClinicalTrials.gov

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