A Phase 1 interventional study of RPX7009 and RPX2014 in Healthy Subjects, sponsored by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company). Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-05.
Sponsored by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) · Phase 1, Interventional, and Treatment
RPX7009(beta-lactamase inhibitor) is being studied in combination with a 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 pharmacokinetics of intravenous RPX2014 and RPX7009 in plasma and epithelial fluid.
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects who have any clinically significant abnormalities on laboratory values at screening (or Day -1), including:
Multiple dose of Carbavance
Drug: RPX7009 and RPX2014
The study is designed to enroll approximately 25 healthy subjects. The study will evaluate the plasma, epithelial lining fluid, and alveolar macrophage concentrations of Carbavance (RPX7009/RPX2014)
Pharmacokinetics from baseline through the end of the study
Assessment of plasma, ELF and AM concentrations of RPX2014 and RPX7009 after 3 doses of Carbavance
Time frame: 2 days
IV Carbavance concentrations in lung fluid
Plasma, ELF and AM concentrations of intravenous Carbavance in healthy adult subjects.
Time frame: 2 days
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)