Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation

Exclusion Criteria

• •Any acute infection that requires treatment or hospitalization within 2 weeks of Study Day 1
• •Colonization with organisms associated with more rapid decline in pulmonary status, such as Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus
• •Any change in the regimen for chronic therapies for CF lung disease (e.g., Pulmozyme®, hypertonic saline, Azithromycin, TOBI®, Cayston®) within 4 weeks of Study Day 1
• •Are pregnant, planning a pregnancy, or breast-feeding at screening
• •Blood hemoglobin \< 10 g/dL at screening
• •Serum albumin \< 2.5 g/dL at screening
• •Abnormal liver function defined as ≥ 3 x upper limit of normal (ULN)
• •History of abnormal renal function within 3 months of screening
• •History of ventricular tachycardia or other clinically significant ventricular arrhythmias
• •History, including the screening assessment, of prolonged QT and/or QTcF (Fridericia's correction) interval
• •History of solid organ or hematological transplantation
• •History of alcohol abuse or drug abuse
• •Ongoing participation in another therapeutic clinical trial
• •Use of continuous (24 hr/day) or nocturnal supplemental oxygen