Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects

Phase 1 Completed 55 enrolled Novartis Pharmaceuticals

Non-randomizedParallel-groupOpen-labelOther

Summary

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.

Timeline

Start: 2011-07
Primary completion: 2011-12
Completion: 2011-12

Publications

Kobalava Z, Villevalde S, Kotovskaya Y, Hinrichsen H, Petersen-Sylla M, Zaehringer A, Pang Y, Rajman I, Canadi J, Dahlke M, Lloyd P, Halabi A. Pharmacokinetics of serelaxin in patients with hepatic impairment: a single-dose, open-label, parallel group study. Br J Clin Pharmacol. 2015 Jun;79(6):937-45. doi: 10.1111/bcp.12572.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Serelaxin	Protein / enzyme biologic	30 ug/kg	Intravenous

Indications

No indication recorded.