Pharmacokinetics of LCZ696 in Subjects With Mild and Moderate Renal Impairment Compared to Healthy Subjects With Normal Renal Function

Novartis Pharmaceuticals32 enrolled

Overview

The purpose of this study is to determine the multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with mild to moderate renal impairment and to evaluate the safety of LCZ696 in this population.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Mild and Moderate Renal Impairment

Interventions

LCZ696DRUG

LCZ696 400 mg once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male, and female subjects of non-child bearing potential, 2. Subjects were to weigh at least 50 kg to participate in the study, 3. and body mass index \< 40 kg/m2 4. Subjects were able to communicate well with the investigator, to understand and comply with the requirements of the study; 5. Subjects were able to understand and sign the written informed consent; For renal insufficient subjects: 1. stable renal disease without evidence of renal progressive * mild renal function: calculated CrCl of 50-≤80 mL/min * moderate renal function: calculated CrCl of 30-\<50 mL/min 2. Vital signs: * oral body temperature between 35.0-37.8 °C * systolic blood pressure, 95-180 mm Hg * diastolic blood pressure, 60-110 mm Hg * pulse rate, 54-95 bpm For healthy subjects only 1. A serum creatinine with a calculated CrCl of \>80 mL/min 2. Vital signs: * oral body temperature between 35.0-37.2 °C * systolic blood pressure, 95-140 mm Hg * diastolic blood pressure, 60-100 mm Hg * pulse rate, 45-90 bpm Exclusion Criteria: 1. Current use of ACE inhibitors, valsartan, and drugs that were known as CYP2C9 substrates, potassium-sparing diuretics; 2. Smokers; 3. History of renal transplant at any time in the past and on immunosuppressant therapy; 4. Dialysis patients; 5. Medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome; 6. Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance; Other protocol defined inclusion/exclusion criteria may apply

Locations (3)

Novartis Investigative Site

Neuss, Germany

Novartis Investigative Site

Moscow, Russia

Novartis Investigative Site

Belgrade, Serbia

Outcomes

Primary Outcomes

Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)