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Completed

NCT Number: NCT01621633

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

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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Key information

Conditions

Hepatic Impairment

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site

Grünstadt, D-67269, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LCZ696

Drug

Primary outcomes

  1. Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)

    Time frame: From pre-dose on Day 1 until 96h post-dose (Day 5)

    Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing

  2. Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time [AUCinf)] of LCZ696 Analytes (AHU377, LBQ657, and Valsartan)

    Time frame: From pre-dose on Day 1 until 96h post-dose (Day 5)

    Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing

  3. Maximum Plasma Concentration (Cmax) for LCZ696 Analytes (AHU377, LBQ657, and Valsartan)

    Time frame: From pre-dose on Day 1 until 96h post-dose (Day 5)

    Blood samples were taken on Day 1 (treatment day) within 60 minutes prior to dosing, then, 0.5,1,1.5,2,3,4,6,8,12 hours after the dosing and on Days 2, 3, 4 and 5 post dosing

Secondary outcomes

  1. Number of Participants With Adverse Events, Serious Adverse Events and Death

    Time frame: From the screening visit until Day 5

    Adverse events, serious adverse events and death were monitored from screening to end of study

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 18, 2012
Registry last updated
Aug 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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