VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers

Phase 1 Completed 53 enrolled Basilea Pharmaceutica National Institute of Allergy and Infectious Diseases (NIAID) · collab

RandomizedSequentialDouble-blindBasic science

Summary

This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.

Timeline

Start: 2021-06-08
Primary completion: 2021-11-10
Completion: 2021-11-10

Publications

de Oliveira CF, Dorr MB, van de Wetering J, Lowe K, Sabato P, Winchell G, Chen H, McGovern PC. Safety and pharmacokinetics of single and multiple doses of ledaborbactam etzadroxil with or without ceftibuten in healthy volunteers. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0021025. doi: 10.1128/aac.00210-25. Epub 2025 Aug 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftibuten	Small molecule	400 mg	—
Subject	Ledaborbactam etzadroxil	Small molecule	300 mg	Oral
Subject	Ledaborbactam etzadroxil	Small molecule	500 mg	Oral

Indications

No indication recorded.