Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function

Phase 1 Completed 32 enrolled Basilea Pharmaceutica National Institute of Allergy and Infectious Diseases (NIAID) · collab

Non-randomizedParallel-groupOpen-labelBasic science

Summary

This is an open-label, multicenter, parallel-group study in participants with normal renal function, mild, moderate, or severe renal impairment, or end stage renal disease (ESRD) undergoing standard intermittent dialysis. The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.

Timeline

Start: 2022-10-12
Primary completion: 2023-11-23
Completion: 2023-11-23

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ceftibuten	Small molecule	—	Oral
Subject	Ledaborbactam etzadroxil	Small molecule	—	Oral

Indications

No indication recorded.