Pharmacokinetics of serelaxin in patients with hepatic impairment: a single-dose, open-label, parallel group study.

ABSTRACT:

Aims

Serelaxin is a recombinant form of human relaxin-2 in development for treatment of acute heart failure. This study aimed to evaluate the pharmacokinetics (PK) of serelaxin in patients with hepatic impairment. Secondary objectives included evaluation of immunogenicity, safety and tolerability of serelaxin.

Methods

This was an open-label, parallel group study (NCT01433458) comparing the PK of serelaxin following a single 24 h intravenous (i.v.) infusion (30 μg kg(-1)  day(-1) ) between patients with mild, moderate or severe hepatic impairment (Child-Pugh class A, B, C) and healthy matched controls. Blood sampling and standard safety assessments were conducted. Primary non-compartmental PK parameters [including area under the serum concentration-time curve AUC(0-48 h) and

SUBMITTER: Kobalava Z 

PROVIDER: S-EPMC4456126 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature