NCT01751269

Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• 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 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 RPX7009, administered alone, in healthy adult subjects.

Conditions

• Healthy Volunteers
• Bacterial Infections

Interventions

Type	Name	Description
DRUG	RPX7009	Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.
DRUG	Placebo	Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-12-17
• Last updated: 2013-07-24

Locations

1 site across 1 country: Australia