NCT03182504

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

A Non-Randomized, Open Label, One Treatment, One Group Study to Investigate the Intrapulmonary Lung Penetration of RO7079901 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gram-negative Bacterial Infections

Interventions

Type	Name	Description
DRUG	nacubactam	Participants will receive a single 2000 milligram (mg) intravenous (IV) infusion of nacubactam over 1.5 hours.
DRUG	meropenem	Participants will receive a single 2000 mg IV infusion of meropenem over 1.5 hours.

Timeline

• Start date: 2017-06-15
• Primary completion: 2017-08-10
• Completion: 2017-08-10
• First posted: 2017-06-09
• Last updated: 2018-04-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study