Study to Evaluate the Safety and Efficacy of CTP-656 in Patients With Cystic Fibrosis With CFTR Gating Mutations

Exclusion Criteria

• •Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment
• •Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes
• •History of hepatitis C or chronic active hepatitis B infection
• •History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening
• •Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening
• •Abnormal liver function
• •History of abnormal renal function
• •History of prolonged QTcF \> 450 msec for males or QTcF \> 470 msec for females
• •History of solid organ or hematological transplantation
• •Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening
• •Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose