Study of Ataluren (PTC124) in Cystic Fibrosis

Exclusion Criteria

• •Chronic use of systemic tobramycin within 4 weeks prior to screening.
• •Evidence of pulmonary exacerbation or acute upper or lower respiratory tract infection (including viral illnesses) within 3 weeks prior to screening or between screening and randomization.
• •Any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for CF or for CF-related conditions within 4 weeks prior to screening and randomization.
• •Known hypersensitivity to any of the ingredients or excipients of the study drug.
• •Exposure to another investigational drug within 4 weeks prior to screening.
• •Treatment with intravenous antibiotics within 3 weeks prior to screening.
• •History of solid organ or hematological transplantation.
• •Ongoing immunosuppressive therapy (other than corticosteroids).
• •Positive hepatitis B surface antigen, hepatitis C antibody test or human immunodeficiency virus (HIV) test.
• •Known portal hypertension.
• •Pregnancy or breast-feeding.