An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Novartis Investigative Site
Neuss, Germany
Novartis Investigative Site
Moscow, Russia
Novartis Investigative Site
Belgrade, Serbia
Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
Time frame: 1 and 5 days
(Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
Time frame: 1 and 5 days
AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
Time frame: 1 and 5 days
T1/2 After Multiple Dose Administration (Day 5)
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
Time frame: 5 days
CL/F After Multiple Dose Administration (Day 5)
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
Time frame: 5 days
CLr After Multiple Dose Administration (Day 5)
Summary statistics for plasma PK parameters following 5 days QD dose of 400mg LCZ696
Time frame: 5 days
24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers
Time frame: 5 days
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