Trials Sponsors Conditions Drugs Pricing

Conditions

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

Outcome Measures

Primary Outcomes (1)

Safety from baseline through the end of the study
Number of patients with adverse events; assessed by patient reporting, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis
7days

Study Arms (1)

Single dose of RPX7009 and RPX2014

EXPERIMENTAL

Single dose of combination RPX7009 and RPX2014

Drug: RPX7009 and RPX2014

Interventions

RPX7009 and RPX2014Drug

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.

Single dose of RPX7009 and RPX2014

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males and females aged 18 through 80 years of age
Willing to abstain from alcohol for 48 hours prior to dosing through discharge

Sponsors & Collaborators

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

Study Sites (2)

DaVita Clinical Research

Lakewood, Colorado, 80228, United States

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Related Publications (1)

Rubino CM, Bhavnani SM, Loutit JS, Lohse B, Dudley MN, Griffith DC. Single-Dose Pharmacokinetics and Safety of Meropenem-Vaborbactam in Subjects with Chronic Renal Impairment. Antimicrob Agents Chemother. 2018 Feb 23;62(3):e02103-17. doi: 10.1128/AAC.02103-17. Print 2018 Mar.
PMID: 29311069DERIVED

MeSH Terms

Interventions

RPX7009

Study Officials

Chris Galloway, MD
Da Vita Clinical Research
PRINCIPAL INVESTIGATOR
Jolene K Berg, MD
Da Vita Clinical Research
PRINCIPAL INVESTIGATOR

Enrollment

32 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 25, 2013

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Single dose of RPX7009 and RPX2014

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Single dose of RPX7009 and RPX2014

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations