{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["13(3)"],"submitter":["Katsube T"],"funding":["Shionogi"],"pubmed_abstract":["<h4>Introduction</h4>Ensitrelvir, a novel oral inhibitor of 3C-like protease of SARS-CoV-2, shows efficacy and safety in participants with mild to moderate COVID-19. Since urinary recovery of ensitrelvir ranged from 12.9% to 21.8% across dose groups given 20-1000 mg in a single-ascending dose study, renal excretion contributes to the elimination of ensitrelvir. Therefore, the effect of renal impairment on the pharmacokinetics and safety of ensitrelvir needed to be evaluated.<h4>Methods</h4>This study (NCT05363215) was a phase 1, open-label, nonrandomized, parallel-group study. The effect of renal function on the pharmacokinetics of ensitrelvir was investigated. Ensitrelvir was administered as a single dose of 375 mg to participants with normal renal function and those with mild, moderate, "],"journal":["Infectious diseases and therapy"],"pagination":["597-607"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10965878"],"repository":["biostudies-literature"],"pubmed_title":["Effect of Renal Impairment on Pharmacokinetics and Safety of Ensitrelvir, a SARS-CoV-2 3CL Protease Inhibitor."],"pmcid":["PMC10965878"],"pubmed_authors":["Shimizu R","Kubota R","Katsube T","Kezbor S"],"additional_accession":[]},"is_claimable":false,"name":"Effect of Renal Impairment on Pharmacokinetics and Safety of Ensitrelvir, a SARS-CoV-2 3CL Protease Inhibitor.","description":"<h4>Introduction</h4>Ensitrelvir, a novel oral inhibitor of 3C-like protease of SARS-CoV-2, shows efficacy and safety in participants with mild to moderate COVID-19. Since urinary recovery of ensitrelvir ranged from 12.9% to 21.8% across dose groups given 20-1000 mg in a single-ascending dose study, renal excretion contributes to the elimination of ensitrelvir. Therefore, the effect of renal impairment on the pharmacokinetics and safety of ensitrelvir needed to be evaluated.<h4>Methods</h4>This study (NCT05363215) was a phase 1, open-label, nonrandomized, parallel-group study. The effect of renal function on the pharmacokinetics of ensitrelvir was investigated. Ensitrelvir was administered as a single dose of 375 mg to participants with normal renal function and those with mild, moderate, ","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Mar","modification":"2025-04-25T21:39:11.107Z","creation":"2025-04-06T08:46:47.16Z"},"accession":"S-EPMC10965878","cross_references":{"pubmed":["38460082"],"doi":["10.1007/s40121-024-00946-x"]}}