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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Group 1: mild hepatic impairment

LCZ696 200 mg, given as a single oral dose

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

Group 2: moderate hepatic impairment

LCZ696 200 mg, given as a single oral dose

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

Group 3: healthy volunteers

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

Group Type EXPERIMENTAL

LCZ696

Intervention Type DRUG

Interventions

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LCZ696

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes