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

NCT01751269 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-07-24

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)

    lead INDUSTRY

Principal Investigators

  • Jefferey Loutit, MBChB · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01751269 on ClinicalTrials.gov