NCT01772836

Safety Study of Intravenous Biapenem (RPX2003) and RPX7009 Given Alone and in Combination

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Biapenem (RPX2003) and RPX7009 Given Alone and in Combination in Healthy Adult Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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 (RPX2003 or biapenem) 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 and pharmacodynamics of Intravenous Biapenem and RPX7009, administered alone and in combination in healthy adult subjects.

Conditions

• Healthy Volunteers
• Bacterial Infections

Interventions

Type	Name	Description
DRUG	RPX7009	Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)
DRUG	Biapenem	Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)
DRUG	Normal saline	Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2013-01-21
• Last updated: 2013-07-11

Locations

1 site across 1 country: Australia