Pharmacokinetics and Safety of Single-Dose Apraglutide in Individuals with Normal and Impaired Hepatic Function: A Phase 1, Open-Label Trial.

ABSTRACT: Intestinal failure-associated liver disease occurs in 20% to 30% of patients with short bowel syndrome and intestinal failure (SBS-IF). Apraglutide is a glucagon-like peptide-2 (GLP-2) analog in clinical development for the treatment of patients with SBS-IF. This study assessed the potential for changes in exposure of apraglutide in individuals with impaired hepatic function versus healthy volunteers. In this Phase 1, open-label, nonrandomized, single-dose trial, apraglutide 3.5 mg was administered to participants with moderate hepatic impairment (Child-Pugh B) or normal hepatic function. Primary pharmacokinetic endpoints were area under the plasma concentration-time curve (AUC) from time 0 to infinity (AUC_inf) or AUC from time 0 to last quantifiable concentration (AUC_last<

SUBMITTER: Greig G 

PROVIDER: S-EPMC12811208 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature