A study to assess the pharmacokinetics of LCZ696 in subjects with hepatic impairment compared to matched healthy subjects

• Conditions: Mild and moderate hepatic impairment; MedDRA version: 14.1Level: PTClassification code 10024670Term: Liver disorderSystem Organ Class: 10019805 - Hepatobiliary disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-000983-27-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-14
• Last Update Posted: 4 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: To assess safety and tolerability of LCZ696 200 mg administered as single dose in subjects with mild and moderate hepatic impairment and their matched healthy control subjects.;Timepoint(s) of evaluation of this end point: From pre-dose on Day 1 until 96h post-dose (Day 5).;Primary end point(s): - 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).<br>- Area under the plasma concentration-time profile from time zero extrapolated to infinite time [AUC(0-inf)] of LCZ696 analytes (AHU377, LBQ657, and valsartan).<br>- Maximum plasma concentration (Cmax) for LCZ696 analytes (AHU377, LBQ657, and valsartan).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number of participants with adverse events, serious adverse events and death.;Timepoint(s) of evaluation of this end point: From the screening visit until Day 5.