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

Inclusion criteria

• Male, and female subjects of non-child bearing potential,
• Subjects were to weigh at least 50 kg to participate in the study,
• and body mass index < 40 kg/m2
• Subjects were able to communicate well with the investigator, to understand and comply with the requirements of the study;
• Subjects were able to understand and sign the written informed consent;

For renal insufficient subjects:

• 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
• 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

• A serum creatinine with a calculated CrCl of >80 mL/min
• 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

• Current use of ACE inhibitors, valsartan, and drugs that were known as CYP2C9 substrates, potassium-sparing diuretics;
• Smokers;
• History of renal transplant at any time in the past and on immunosuppressant therapy;
• Dialysis patients;
• Medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome;
• 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