Subjects With Normal Renal Function Clinical Trial
Official title:
A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Carbavance™ (RPX2014/RPX7009) in Subjects With Renal Insufficiency
RPX7009(beta-lactamase inhibitor) is being studied in combination with carbapenem (RPX2014)to treat bacterial infections, including those due to multi-drug resistant bacteria.
The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly
members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of
hospital acquired infections. In particular, the recent dissemination of a serine
carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable
threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.
Rempex is developing a fixed combination antibiotic of a carbapenem (RPX2014) plus a new
beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases,
including KPC. This Phase 1 study will assess the safety, tolerability and pharmacokinetics
of intravenous RPX2014 and RPX7009, administered in combination in subjects with varying
degrees of renal insufficiency.
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