Phase I trial to investigate the effect of renal impairment on isavuconazole pharmacokinetics.

ABSTRACT:

Purpose

The purpose of the study is to evaluate the effect of renal impairment (RI) and end-stage renal disease (ESRD) on the pharmacokinetics (PK) of isavuconazole and the inactive cleavage product, BAL8728.

Methods

A single intravenous dose of the prodrug isavuconazonium sulfate (372 mg, equivalent to 200 mg isavuconazole and 75 mg of BAL8728 cleavage product) was administered to healthy controls (parts 1 and 2) and participants with mild, moderate, or severe RI (part 2) or ESRD (part 1); ESRD participants received two doses of 200 mg isavuconazole, 1 h post-dialysis (day 1) and prior to dialysis (day 15). Plasma PK parameters for isavuconazole included maximum concentration (C _max), area under the concentration-time curve (AUC) from time of dose to 72 h (AUC

SUBMITTER: Townsend RW 

PROVIDER: S-EPMC5423998 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature