Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Homozygous for the F508del-CFTR Mutation

Exclusion Criteria

• •History of any illness or condition that might confound the results of the study or pose an additional risk in administering study drug to the subject
• •Acute respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks of Day 1 of the study
• •History of alcohol, medication or illicit drug abuse within one year prior to Day 1
• •Abnormal liver function \>=3 x the upper limit of normal
• •Abnormal renal function at Screening
• •History of solid organ or hematological transplantation
• •Pregnant or breast-feeding (for women)
• •Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days prior to screening
• •Previous participation in a VX-809 study
• •Used inhaled hypertonic saline treatment
• •Concomitant use of any inhibitors or inducers of cytochrome P450 3A4 (CYP3A4)