Effect of severe renal impairment on pharmacokinetics, safety, and tolerability of lemborexant.

ABSTRACT: The primary aim of this study was to examine the effect of severe renal impairment (SRI) on the pharmacokinetics of lemborexant, a dual orexin receptor antagonist indicated for the treatment of insomnia. A phase 1 multicenter, single-dose, open-label, parallel-group study was conducted in subjects with SRI not requiring dialysis (estimated glomerular filtration rate 15-29 ml/min/1.73 m² ; n = 8) compared with demographically matched healthy subjects with normal renal function (n = 8). Plasma levels of lemborexant and its metabolites were measured over 240 h following a single oral 10-mg dose administered in the morning. Relative to subjects with normal renal function, lemborexant maximum plasma concentration (C_max ) was similar, whereas area under the plasma concentra

SUBMITTER: Landry I 

PROVIDER: S-EPMC7945683 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature