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

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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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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