{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["66(5)"],"submitter":["Patel G"],"funding":["Spero Therapeutics"],"pubmed_abstract":["Tebipenem pivoxil hydrobromide (TBP-PI-HBr) is an oral carbapenem prodrug antimicrobial agent with broad-spectrum activity that includes multidrug-resistant (MDR) <i>Enterobacterales</i>. This study evaluated the safety, tolerability, and pharmacokinetics of TBP-PI-HBr in healthy subjects with normal renal function (cohort 1) and subjects with various degrees of renal impairment (RI [cohorts 2 to 4]) or end-stage renal disease (ESRD) receiving hemodialysis (HD) (cohort 5). Subjects in cohorts 1 to 4 received a single oral dose of TBP-PI-HBr (600 mg). Subjects in cohort 5 received single-dose administration (600 mg) in 2 separate periods: pre-HD (period 2) and post-HD (period 1). Pharmacokinetic (PK) parameters for TBP, the active moiety, were determined using noncompartmental analysis. Com"],"journal":["Antimicrobial agents and chemotherapy"],"pagination":["e0240721"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9112917"],"repository":["biostudies-literature"],"pubmed_title":["Pharmacokinetics of Oral Tebipenem Pivoxil Hydrobromide in Subjects with Various Degrees of Renal Impairment."],"pmcid":["PMC9112917"],"pubmed_authors":["Talley AK","Gasink L","Jain A","Bruss J","Lei Y","Bajraktari F","Patel G","Gupta VK","Rodvold KA","Srivastava P"],"additional_accession":[]},"is_claimable":false,"name":"Pharmacokinetics of Oral Tebipenem Pivoxil Hydrobromide in Subjects with Various Degrees of Renal Impairment.","description":"Tebipenem pivoxil hydrobromide (TBP-PI-HBr) is an oral carbapenem prodrug antimicrobial agent with broad-spectrum activity that includes multidrug-resistant (MDR) <i>Enterobacterales</i>. This study evaluated the safety, tolerability, and pharmacokinetics of TBP-PI-HBr in healthy subjects with normal renal function (cohort 1) and subjects with various degrees of renal impairment (RI [cohorts 2 to 4]) or end-stage renal disease (ESRD) receiving hemodialysis (HD) (cohort 5). Subjects in cohorts 1 to 4 received a single oral dose of TBP-PI-HBr (600 mg). Subjects in cohort 5 received single-dose administration (600 mg) in 2 separate periods: pre-HD (period 2) and post-HD (period 1). Pharmacokinetic (PK) parameters for TBP, the active moiety, were determined using noncompartmental analysis. Com","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 May","modification":"2025-04-04T19:31:27.935Z","creation":"2025-02-19T02:57:37.382Z"},"accession":"S-EPMC9112917","cross_references":{"pubmed":["35420493"],"doi":["10.1128/aac.02407-21"]}}