The study is designed to evaluate the pharmacokinetics, safety and tolerability, immunogenicity and pharmacogenetics of a single dose of serelaxin/RLX030 in patients with severe renal impairment and end-stage-renal-disease (ESRD) compared to healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
Novartis Investigative Site
Grünstadt, Germany
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
Time frame: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
The area under the serum concentration-time curve from time zero to 28 hours after administration (AUC 0-28hr)
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
Time frame: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
The area under the serum concentration-time curve from time zero to infinity (AUCinf)
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
Time frame: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
The observed maximum serum concentration following drug administration (Cmax)
Blood samples will be collected on days 1 through 3 and then on Day 15 for the determination of serum concentrations of serelaxin
Time frame: pre-treatment, 15 min, 1, 2, 3, 4, 4:15, 5, 6, 7, 8, 9, 10, 12, 24, 28, 36, 48 hours and day 15
Percentage of patients with reported adverse events, serious adverse events and death.
Time frame: From Day -21 to Day 15
Percentage of patients developing anti-RLX030 antibodies
Time frame: Day 1 (pre-treatment) and Day 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.