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Keep this study
Lead
Novartis Pharmaceuticals
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
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 \[group 4\])
