Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

Phase 1 Completed 24 enrolled Basilea Pharmaceutica National Institute of Allergy and Infectious Diseases (NIAID) · collab

Non-randomizedCrossoverOpen-labelTreatment

Summary

This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). 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: 2022-09-13
Primary completion: 2023-02-06
Completion: 2023-02-10

Drugs

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

Indications

No indication recorded.