Evidence map›Paper›PMID 40762486›Full record

Trial reportAntimicrobial agents and chemotherapy2025

Safety and pharmacokinetics of single and multiple doses of ledaborbactam etzadroxil with or without ceftibuten in healthy volunteers.

Carlos Fernando de Oliveira, Mary Beth Dorr, Jeroen van de Wetering, Kathryn Lowe, Philip Sabato, Gregory Winchell, Hongzi Chen, Paul C McGovern

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Carlos Fernando de OliveiraVenatorx Pharmaceuticals, Inc., Malvern, Pennsylvania, USA.ORCID 0009-0002-4989-4896
Mary Beth DorrVenatorx Pharmaceuticals, Inc., Malvern, Pennsylvania, USA.
Jeroen van de WeteringPRA Health Sciences, Groningen, the Netherlands.
Kathryn LoweVenatorx Pharmaceuticals, Inc., Malvern, Pennsylvania, USA.
Philip SabatoVenatorx Pharmaceuticals, Inc., Malvern, Pennsylvania, USA.
Gregory WinchellWinchell Pharma Consulting, LLC, Norristown, Pennsylvania, USA.
Hongzi ChenVenatorx Pharmaceuticals, Inc., Malvern, Pennsylvania, USA.
Paul C McGovernVenatorx Pharmaceuticals, Inc., Malvern, Pennsylvania, USA.ORCID 0000-0002-5906-2818

Funding

NIAID NIH HHS HHSN272201600029C
6 · The paper itself

Abstract

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 (

Indexed as

Anti-Bacterial AgentsCephalosporinsAdolescentAdultDouble-Blind MethodDrug InteractionsFemaleHealthy VolunteersHumansMaleMiddle AgedProdrugsYoung AdultAnti-Bacterial AgentsCephalosporinsProdrugsbeta-lactamase inhibitorceftibutendrug safetyfirst-in-humanledaborbactamledaborbactam etzadroxilpharmacokineticsVNRX-5236VNRX-7145

Identifiers

PMID40762486
PMCPMC12406652

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.