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The Safety and Pharmacokinetics of Carbavance™ (RPX2014/RPX7009) in Subjects With Renal Insufficiency

NCT02020434 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-03-05

No results posted yet for this study

Summary

RPX7009(beta-lactamase inhibitor) is being studied in combination with carbapenem (RPX2014)to treat bacterial infections, including those due to multi-drug resistant bacteria.

Conditions

  • Subjects With Varying Degrees of Renal Insufficiency and
  • Subjects With Normal Renal Function

Interventions

DRUG

RPX7009 and RPX2014

The study is designed to enroll approximately 32 subjects. There will be approximately 24 subjects with varying degrees of renal insufficiency and approximately 8 subjects with normal renal function.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Chris Galloway, MD · Da Vita Clinical Research

  • Jolene K Berg, MD · Da Vita Clinical Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-09-30
Completion
2014-10-31

Countries

  • United States

Study Locations

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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 NCT02020434 on ClinicalTrials.gov