Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects

All subjects:

Inclusions Criteria:

- Subjects must weight at least 50 kg, with a BMI within the range of 18 to 38 kg/m2

- Must be willing to remain in the clinical research unit as required by the protocol

Exclusion Criteria:

- Use of other study drugs at the time of enrollment, or within 5 half-lives of
enrollment, or within 30 days, whichever is longer; or longer if required by local
regulations

- History of hypersensitivity to the study treatment or to drugs of similar chemical
classes

- Pregnant or nursing women

- Women of child-bearing potential

Healthy Volunteers:

Inclusion Criteria:

- In good health as determined by past medical history, physical examination, ECG,
laboratory tests, and urinalysis at Screening.

Exclusion Criteria:

- Liver disease or liver injury

- Chronic infection with Hepatitis B or Hepatitis C

- History or presence of impaired renal function

Hepatically Impaired Subjects:

Inclusion Criteria:

- Hepatic impairment as defined by the Child-Pugh classification for severity of liver
disease

Exclusion Criteria:

- Severe complications of liver disease within the preceding 3 months

- Emergency room visit or hospitalization due to liver disease within the preceding 3
months

- Subject has received liver transplant at any time in the past and is on
immunosuppressant therapy

- Acute Hepatitis B or Hepatitis C infection

Other protocol-defined inclusion/exclusion criteria may apply.