drugset

drugset / Trial / NCT06547554

A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants

NCT06547554 ↗

Phase 1 Completed 60 enrolled Qpex Biopharma, Inc. Biomedical Advanced Research and Development Authority · collab Shionogi · collab

RandomizedCrossoverTriple-blindTreatment

Summary

A phase 1, randomized, double blind, placebo controlled drug-drug interaction, pharmacokinetics and safety study of cefiderocol in combination with xeruborbactam in healthy adult participants

Timeline

Start: 2024-09-04
Primary completion: 2025-10-27
Completion: 2025-10-27

Publications

Gonzalez-Pinto L, Gomis-Font MA, Perez-Rodriguez G, Blanco-Martin T, Rodriguez-Pallares S, Sanchez-Pena L, Beceiro A, Bou G, Jeannot K, Oliver A, Arca-Suarez J. Contribution of mutational resistance mechanisms and acquired beta-lactamases to cefiderocol/xeruborbactam susceptibility in Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2025 Dec 10;69(12):e0104825. doi: 10.1128/aac.01048-25. Epub 2025 Oct 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cefiderocol	Small molecule	—	—
Subject	Xeruborbactam	Small molecule	—	—

Indications