This study will assess the pharmacokinetics of RLX030 during and after administration in subjects with mild to severe hepatic impairment and matched healthy control subjects. 20 to 24 patients and 20 to 24 healthy subjects will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
55
RLX030 is administered as a continuous 24 hour infusion
Novartis Investigative Site
Grünstadt, Germany
Novartis Investigative Site
Moscow, Russia
Area under the serum concentration-time curve from time zero to infinity (AUCinf)
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Time frame: Up to Day 15
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Time frame: Up to Day 15
Serum concentration at 24 hour (C24h) after administration
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Time frame: Upto Day 15
Number of patients with adverse events, serious adverse events and death
Monitoring of adverse events, serious adverse events and death from screening to end of study
Time frame: Day 15
Determination of the presence and quantification of anti-RLX030 antibodies
Blood will be collected and serum analyzed for the presence of antiRLX030 antibodies. Anti-RLX030 antibodies will be evaluated in serum in a validated four-tiered assay approach
Time frame: Day 1 (prior to administration) and Day 15 end of study
Mean residence time [MRT] of RLX030
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Time frame: screening, days 1, 2, 3, 4 and 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Terminal elimination half life (T ½) of RLX030
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Time frame: screening, days 1, 2, 3, 4 and 15
Systemic clearance of RLX030 from serum (CL)
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Time frame: screening, days 1, 2, 3, 4 and 15
Volume of distribution at steady state (Vss)
Blood samples will be collected during screening, days 1 through 4 and then on Day 15 for the determination of serum concentrations of RLX030
Time frame: screening, days 1, 2, 3, 4 and 15