Single-dose Pharmacokinetics of Eluxadoline in Healthy Participants With Normal Renal Function and Participants With Renal Impairment.

ABSTRACT: Eluxadoline is approved for the treatment of diarrhea-predominant irritable bowel syndrome in the United States. The impact of renal impairment on the pharmacokinetic (PK) parameters of eluxadoline is currently unknown. This phase 1, open-label, parallel-group study evaluated the PK and safety profile of eluxadoline in 8 participants with renal impairment and 8 matched healthy controls. Of the participants with renal impairment, 2 had severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m² ) and 6 had end-stage renal disease while not yet on dialysis (eGFR <15 mL/min/1.73 m² ). The primary objective was to assess plasma and urine PKs, and plasma protein binding of eluxadoline. In participants with renal impairment, mean plasma concentra

SUBMITTER: Boinpally R 

PROVIDER: S-EPMC10108264 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature