Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects

Inclusion Criteria:

Group A: Subjects with Moderate Hepatic Impairment

• Male and female 18 to 65 years of age (inclusive)
• Satisfy the criteria for moderate hepatic impairment defined as a Child Pugh total score of 7 to 9 (Child Pugh Class B) at the Screening Visit
• Willing and able to comply with schedule visits, treatment, laboratory tests, and contraceptive guidelines.

Group B: Healthy subjects

• Male and female 18 to 65 years of age (inclusive)
• Healthy subjects with no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, including blood pressure and pulse rate measurement, standard 12-lead ECG, and clinical laboratory tests
• Willing and able to comply with schedule visits, treatment, laboratory tests, contraceptive guidelines and other study procedures

Exclusion Criteria:

Group A: Subjects with Moderate Hepatic Impairment

• History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
• Have fluctuating or rapidly deteriorating hepatic function by history or as indicated by significant variations in or worsening of clinical and/or laboratory signs of hepatic impairment within 6 months before the Screening Visit
• Other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver
• Severe hepatic encephalopathy
• Type 1 diabetes mellitus or evidence of poorly controlled type 2 diabetes
• Hepatocellular carcinoma, HIV, hepatitis B/C
• Significant renal dysfunction
• Solid organ or bone marrow transplantation
• History of regular alcohol consumption, drug abuse or regular smoking

Group B: Healthy subjects

• History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject
• History of regular alcohol consumption, drug abuse or regular smoking