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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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