Assessment of pharmacokinetics and tolerability following single-dose administration of molnupiravir in participants with hepatic or renal impairment.

ABSTRACT: Individuals with chronic liver or kidney disease are at increased risk of severe COVID-19. Molnupiravir is an orally administered antiviral authorized for the treatment of mild-to-moderate COVID-19 in adults at risk of progression to severe disease. Two nonrandomized, open-label, single-dose, multicenter, phase 1 trials were conducted to investigate the effects of hepatic and renal impairment on the tolerability and pharmacokinetics of molnupiravir (800 mg) and its metabolite β-D-N4-hydroxycytidine (NHC; NCT05386589/NCT05386758). The impact of renal impairment on urinary excretion of NHC was also assessed. The 90% CI for the geometric mean ratio of the plasma NHC area under the concentration-time curve (AUC) from zero to infinity was <2.0 for participants with moderate hepatic or severe re

SUBMITTER: Duncan KE 

PROVIDER: S-EPMC11599873 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature