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

NCT02020434 | Completed Phase 1

• 1 other identifier: Rempex 504
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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

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 RPX2014 DRUG

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• Normal volunteer first matched by age (± 10 years), BMI (± 20%), and gender to the mean values of the moderate renal insufficiency group.
• Have negative test results for HBsAg, anti-HCV antibody and anti-HIV antibody.
• Voluntarily consent to participate in the study
• Sexually abstinent or agree to use two approved methods of contraception.
• Assessment of renal insufficiency for assignment to study groups will be based on measurements of eGFR calculated by the MDRD equation at the Screening Visit to determine eligibility.

You may not qualify if:

• Unstable or new medical conditions (e.g., cardiovascular, respiratory, hepatic, renal, gastrointestinal, autoimmune, endocrine, or neurological disorders)
• Hypersensitivity or idiosyncratic reaction to β-lactam antibiotics (e.g. penicillins, cephalosporins, or carbapenems)
• History of clinically significant seizures, head injury, or meningitis.
• Current evidence or history of malignancy, excluding basal cell carcinoma, in the 2 years prior to Day -1 with no evidence of recurrence.
• Females who are pregnant, lactating, or have a positive pregnancy test
• Previously received any dose of Carbavance (RPX2014/RPX7009).
• Current participation in another investigational study or participation in another investigational clinical study within 30 days prior to the Screening Visit.
• Blood donation or significant blood loss (i.e., \> 500 mL) within 56 days prior to Day 1.
• Plasma or platelet donation within 14 days prior to Day -1.
• Any acute illness requiring antibiotic drug therapy within 30 days prior to Day 1 or a febrile illness within 7 days prior to Day 1.
• Vigorous exercise from 48 hours prior to Day -1 until the day of discharge from the study.
• Positive urine drug/alcohol test at the Screening Visit or Day -1
• Concurrent use of medications known to affect the elimination of serum creatinine (e.g., trimethoprim/sulfamethoxazole \[Bactrim®\] or cimetidine \[Tagamet®\]) and competitors of renal tubular secretion (e.g., probenecid) within 30 days prior to the first dose of study drug
• Abnormal and clinically significant findings on physical examination, medical history, serum chemistry, hematology, or urinalysis
• Use of any other prescription or nonprescription drugs, vitamins, grapefruit/grapefruit juice or dietary or herbal supplements within 14 days prior to Day -1.

Sponsors & Collaborators

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

Study Sites (2)

DaVita Clinical Research

Lakewood, Colorado, 80228, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

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: 29311069 DERIVED

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

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 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

US (2)