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Clinical Trial Summary

A Phase 1, open-label, single-dose study to determine the safety and pharmacokinetics of ORAvance (ceftibuten/xeruborbactam oral prodrug [QPX7831]) in participants with renal impairment


Clinical Trial Description

Qpex Biopharma, Inc. is developing an oral dosage form that delivers Xeruborbactam, a new boron-based beta-lactamase inhibitor with activity against both serine and metallo-beta-lactamases, for oral treatment in combination with a beta-lactam antibiotic. Ceftibuten is a cephalosporin antibiotic approved in the US for acute exacerbations of chronic bronchitis, acute bacterial otitis media and pharyngitis/ tonsillitis. This is a Phase 1 open-label, single-dose study to assess the safety, tolerability, and PK, of ceftibuten and xeruborbactam oral prodrug given in combination to participants with varying degrees of renal impairment as compared to participants with normal renal function. Objectives: The objectives of the study are: 1. To assess the PK of ceftibuten and xeruborbactam oral prodrug given in combination in participants with varying degrees of renal impairment. 2. To evaluate the safety and tolerability of ceftibuten and xeruborbactam oral prodrug given in combination in participants with varying degrees of renal impairment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06157242
Study type Interventional
Source Qpex Biopharma, Inc.
Contact Shawnee Gehrke, MPH
Phone (760) 419-7428
Email sgehrke@qpexbio.com
Status Not yet recruiting
Phase Phase 1
Start date June 1, 2024
Completion date June 1, 2025

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