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

Reference22 articles.

1. Tebipenem, the first oral carbapenem antibiotic

2. Characterization of SPR994, an Orally Available Carbapenem, with Activity Comparable to Intravenously Administered Carbapenems

3. Antimicrobial Activity Evaluation of Tebipenem (SPR859), an Orally Available Carbapenem, against a Global Set of Enterobacteriaceae Isolates, Including a Challenge Set of Organisms