A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers

A Single-dose, Open-label Parallel-group Study to Assess the Pharmacokinetics of LCZ696 in Subjects With Hepatic Impairment Compared to Matched Healthy Subjects

This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment compared to matched healthy subjects

Inclusion Criteria:

• All subjects:

  • Male and female subjects aged 18-75 years.
  • Body weight at least 55 kg with a body mass index between 18-35 kg/m2.

• Hepatic impairment subjects:

  • Mild or moderate hepatic impairment.

Exclusion Criteria:

• All subjects:

  • Clinical manifestations of postural symptomatic hypotension at screening or baseline.
  • History of hypersensitivity to LCZ696 or to drugs of similar classes.

• Hepatic impairment subjects:

  • Hepatic impairment due to non-liver disease.
  • Treatment with any vasodilator, autonomic alpha blocker or beta2 agonist within 2 weeks of dosing.
  • Encephalopathyy Stage III or IV.
  • Primary biliary liver cirrhosis or biliary obstruction.
  • History of gastro-intestinal bleeding within 3 months prior to screening.

• Healthy subjects:

  • Any surgical or medical condition which might significantly alter the distribution, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
  • Use of prescription drugs, herbal supplements, and/or over-the-counter medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing.

Other protocol-defined inclusion/exclusion criteria may apply.