Safety and pharmacokinetics of single and multiple doses of ledaborbactam etzadroxil with or without ceftibuten in healthy volunteers Article Swipe
Carlos Fernando de Oliveira
,
Marcus Dörr
,
Jeroen van de Wetering
,
Kathryn Lowe
,
Philip Sabato
,
Gregory A. Winchell
,
Hongzi Chen
,
Paul C. McGovern
·
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1128/aac.00210-25
YOU?
·
· 2025
· Open Access
·
· DOI: https://doi.org/10.1128/aac.00210-25
Ledaborbactam etzadroxil (LED-E), a novel oral prodrug that converts to the active β-lactamase inhibitor (BLI) ledaborbactam (LED), is being developed in combination with ceftibuten (CTB) to address a need for oral treatments against drug-resistant Enterobacterales infections. Two Phase 1 studies were conducted to (i) evaluate the safety and pharmacokinetics of single doses of LED-E 100 to 1000 mg and multiple doses of LED-E 75 to 500 mg every 8 h (q8h) for 10 days, (ii) assess potential drug interactions between CTB and LED, and (iii) evaluate safety and pharmacokinetics following multiple doses of LED-E 300 or 500 mg with CTB 400 mg or placebo q8h for 10 days. Treatment-emergent adverse events (TEAEs) were reported for 82% LED-E ± CTB ( n = 109) and 78% placebo ( n =27) participants, respectively. TEAEs of gastrointestinal disorders were reported for 28% of the LED-E ± CTB and 15% of placebo participants. Following single doses, LED-E AUC inf was less than 2% of LED exposures, demonstrating extensive conversion to active BLI. LED AUC increased dose proportionally following single LED doses and less than proportionally following multiple LED-E doses. After 10 days of q8h dosing, the LED terminal half-life in plasma was approximately 11 to 12 h. Steady-state urinary excretion of LED-E–derived material (comprised almost entirely of unchanged LED) was 84%. No clinically relevant CTB and LED PK interactions occurred with the CTB + LED-E combination. These results support further development of the CTB + LED-E combination for the treatment of complicated urinary tract infections caused by drug-resistant Enterobacterales. CLINICAL TRIALS These studies are registered with ClinicalTrials.gov as NCT04243863 and NCT04877379 .
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- OpenAlex ID
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All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4413005775Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1128/aac.00210-25Digital Object Identifier
- Title
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Safety and pharmacokinetics of single and multiple doses of ledaborbactam etzadroxil with or without ceftibuten in healthy volunteersWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2025Year of publication
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2025-08-14Full publication date if available
- Authors
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Carlos Fernando de Oliveira, Marcus Dörr, Jeroen van de Wetering, Kathryn Lowe, Philip Sabato, Gregory A. Winchell, Hongzi Chen, Paul C. McGovernList of authors in order
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https://doi.org/10.1128/aac.00210-25Publisher landing page
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YesWhether a free full text is available
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hybridOpen access status per OpenAlex
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https://doi.org/10.1128/aac.00210-25Direct OA link when available
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Pharmacokinetics, Medicine, PharmacologyTop concepts (fields/topics) attached by OpenAlex
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0Total citation count in OpenAlex
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11Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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