A Phase 1 Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Hepatic Function

Inclusion Criteria:

- Weight ≥50 kg and BMI between 18-38kg/m2.

- Stable liver cirrhosis and evidence of hepatic impairment. ‐Free of significant
medical disorders unrelated to underlying hepatic impairment

Exclusion Criteria:

- History of any surgical or medical condition which might significantly alter the
absorption, distribution, metabolism or excretion of drugs

- Subjects with ongoing alcohol or drug abuse

- Symptoms or history of encephalopathy (Grade 2 or above)

- History or presence of liver disease or liver injury (healthy volunteers only)

- History or presence of impaired renal function

- Clinical evidence of severe ascites.

- Total Bilirubin > 6 mg/dL,

- Subjects with a serum free cortisol test results that is below the lower limit
of normal (based on central laboratory) during the screening period

- Concomitant use of a drug that is a strong inducer of the CYP3A4/5 pathway

Other protocol-defined inclusion/exclusion criteria may apply -