The Safety and Pharmacokinetics of Carbavance™ (RPX2014/RPX7009) in Subjects With Renal Insufficiency

NCT02020434 ↗

Phase 1 Completed 32 enrolled Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)

NaSingle-groupOpen-labelTreatment

Summary

RPX7009(beta-lactamase inhibitor) is being studied in combination with carbapenem (RPX2014)to treat bacterial infections, including those due to multi-drug resistant bacteria.

Timeline

Start: 2014-01
Primary completion: 2014-09
Completion: 2014-10

Publications

Rubino CM, Bhavnani SM, Loutit JS, Lohse B, Dudley MN, Griffith DC. Single-Dose Pharmacokinetics and Safety of Meropenem-Vaborbactam in Subjects with Chronic Renal Impairment. Antimicrob Agents Chemother. 2018 Feb 23;62(3):e02103-17. doi: 10.1128/AAC.02103-17. Print 2018 Mar.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RPX2014	Small molecule	1 g	Intravenous
Subject	Vaborbactam	Small molecule	1 g	Intravenous

Indications

No indication recorded.