Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)

Exclusion Criteria

• •Known hypersensitivity to any of the ingredients or excipients of the study drug
• •Previous participation in the Phase 3 trial of ataluren (PTC124-GD-009-CF).
• •Any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for Cystic Fibrosis (CF) or for CF-related conditions within 4 weeks prior to screening
• •Chronic use of inhaled aminoglycosides (eg, tobramycin) or use of inhaled aminoglycosides within 4 weeks prior to screening.
• •Exposure to another investigational drug within 4 weeks prior to screening
• •Ongoing participation in any other therapeutic clinical trial
• •Evidence of pulmonary exacerbation or acute upper or lower respiratory tract infection (including viral illnesses) within 3 weeks prior to screening
• •Treatment with intravenous antibiotics within 3 weeks prior to screening
• •Ongoing immunosuppressive therapy (other than corticosteroids)
• •Ongoing warfarin, phenytoin, or tolbutamide therapy
• •History of solid organ or hematological transplantation
• •Major complications of lung disease (including massive hemoptysis, pneumothorax, or pleural effusion) within 8 weeks prior to screening
• •Known portal hypertension
• •Positive hepatitis B surface antigen, hepatitis C antibody test, or human immunodeficiency virus (HIV) test
• •Pregnancy or breast-feeding
• •Current smoker or a smoking history of \>=10 pack-years (number of cigarette packs/day x number of years smoked).
• •Prior or ongoing medical condition (eg, concomitant illness, alcoholism, drug abuse, psychiatric condition), medical history, physical findings, electrocardiogram (ECG) findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the subject, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results