INC280 in Healthy Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function

Inclusion criteria

(all groups):

• Female subjects must be postmenopausal or sterile
• Good health, as determined by absence of clinically significant findings in medical history, physical examination, vital signs, and ECGs, unless it is consistent with known clinical disease for hepatic impairment subjects
• Adequate organ function and normal laboratory tests, unless it is consistent with known clinical disease for hepatic impairment subjects
• Body Mass Index (BMI) of 18- 36 kg/m2, with body weight ≥ 50 kg

Inclusion criteria

(hepatic impairment groups):

• Confirmed liver disease
• Stable comorbidities are allowed as long as generally considered healthy
• Subjects with hepatic impairment must meet the following laboratory values:
• Aspartate transaminase (AST) ≤ 5 x ULN
• Alanine transaminase (ALT) ≤ 5 x ULN
• Total bilirubin ≤ 3 x ULN (≤ 5 x XULN for subjects with severe hepatic impairment [group 4])
• Calculated creatinine clearance (using Cockcroft-Gault formula) ≥ 45 mL/min
• Platelets > 50 x 10^9/L. Subjects with severe hepatic impairment can be enrolled if platelet count > 40 x 10^9/L

Exclusion criteria

(all groups):

• History or presence of clinically significant ECG abnormalities or clinically significant cardiovascular disease
• Immunocompromised subjects, including HIV
• Use of drugs known to affect CYP3A4
• Use of QT-prolonging drugs
• Use of any other drugs, unless they are required to treat the hepatic impairment subject's disease
• Use of proton pump inhibitors (PPI) medications within 7 days prior to dosing and during the current study until last day of confinement

Exclusion criteria

(normal hepatic function group):

• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result

Exclusion criteria

(hepatic impairment groups):

• Active Grade 3 or 4 hepatic encephalopathy within 4 weeks of study entry
• Clinical evidence of severe ascites
• Ascites requiring paracentesis within 3 weeks prior to dosing

Other protocol-defined inclusion/exclusion criteria may apply.