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 for mildly and moderately hepatically impaired subjects, and within the preceding 1 month for severely hepatically impaired subjects
• 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.