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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01621633
First Posted: June 18, 2012
Last Update Posted: August 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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

Condition Intervention Phase
Hepatic Impairment Drug: LCZ696 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official 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

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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

  • 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

  • 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 Outcome Measures:
  • 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


Enrollment: 32
Study Start Date: September 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: mild hepatic impairment
LCZ696 200 mg, given as a single oral dose
Drug: LCZ696
Experimental: Group 2: moderate hepatic impairment
LCZ696 200 mg, given as a single oral dose
Drug: LCZ696
Experimental: 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
Drug: LCZ696

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621633


Locations
Germany
Novartis Investigative Site
Grunstadt, Germany, D-67269
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01621633     History of Changes
Other Study ID Numbers: CLCZ696B2203
2012-000983-27 ( EudraCT Number )
First Submitted: June 14, 2012
First Posted: June 18, 2012
Results First Submitted: July 11, 2015
Results First Posted: August 10, 2015
Last Update Posted: August 10, 2015
Last Verified: July 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
hepatic impairment

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
LCZ 696
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action