Pharmacokinetics of Oral Tebipenem Pivoxil Hydrobromide in Subjects with Various Degrees of Renal Impairment-Reference-Cited by-同舟云学术

Pharmacokinetics of Oral Tebipenem Pivoxil Hydrobromide in Subjects with Various Degrees of Renal Impairment

Published:2022-05-17 Issue:5 Volume:66 Page:
ISSN:0066-4804
Container-title:Antimicrobial Agents and Chemotherapy
language:en
Short-container-title:Antimicrob Agents Chemother

Author:

Patel Gina¹,Rodvold Keith A.²,Gupta Vipul K.³^ORCID,Bruss Jon³,Gasink Leanne³,Bajraktari Floni³,Lei Yang³,Jain Akash³,Srivastava Praveen³,Talley Angela K.³

Affiliation:

1. Patel Kwan Consultancy, LLC, Madison, Wisconsin, USA

2. University of Illinois, Chicago, Illinois, USA

3. Spero Therapeutics, Inc., Cambridge, Massachusetts, USA

Abstract

Tebipenem pivoxil hydrobromide (TBP-PI-HBr) is an oral carbapenem prodrug antimicrobial agent with broad-spectrum activity that includes multidrug-resistant (MDR) Enterobacterales . 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).

Funder

Spero Therapeutics

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Link

https://journals.asm.org/doi/pdf/10.1128/aac.02407-21

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