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

Novartis

Status and phase: Completed; Phase 2

Conditions: Hepatic Impairment

Treatments: Drug: LCZ696

Study type: Interventional

Funder types: Industry

Identifiers

NCT01621633

CLCZ696B2203

2012-000983-27 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

32 participants in 3 patient groups

Group 1: mild hepatic impairment

Experimental group

Description:

LCZ696 200 mg, given as a single oral dose

Treatment:

Drug: LCZ696

Group 2: moderate hepatic impairment

Experimental group

Description:

LCZ696 200 mg, given as a single oral dose

Treatment:

Drug: LCZ696

Group 3: healthy volunteers

Experimental group

Description:

LCZ696 200 mg, given as a single oral dose. Each healthy volunteer will match in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in groups 1 and 2

Treatment:

Drug: LCZ696