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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: LCZ 696; Sacubitril and valsartan sodium hydrate drug combination

Criteria

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.