drugset / Trial / NCT03182504

A Study to Investigate the Intrapulmonary Lung Penetration of Nacubactam in Healthy Participants

NCT03182504

Phase 1 Completed 21 enrolled Hoffmann-La Roche
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to characterize the intrapulmonary penetration of nacubactam in healthy volunteers. Nacubactam is a novel non-beta-lactam beta-lactamase inhibitor being developed as a combination therapy with the beta-lactam meropenem for the treatment of serious gram-negative bacterial infections. Adult male and female healthy participants will receive a single intravenous infusion of nacubactam co-administered with meropenem and then undergo a bronchoalveolar lavage (BAL) procedure to collect lung epithelial lining fluid (ELF) for measurement of intrapulmonary concentrations of nacubactam and meropenem.

Timeline

Start
2017-06-15
Primary completion
2017-08-10
Completion
2017-08-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Meropenem Small molecule 2000 mg Intravenous
Subject nacubactam Small molecule 2000 mg Intravenous