- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02020434
The Safety and Pharmacokinetics of Carbavance™ (RPX2014/RPX7009) in Subjects With Renal Insufficiency
A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of Carbavance™ (RPX2014/RPX7009) in Subjects With Renal Insufficiency
Study Overview
Status
Conditions
Intervention / Treatment
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 (RPX2014) 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 intravenous RPX2014 and RPX7009, administered in combination in subjects with varying degrees of renal insufficiency.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Colorado
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Lakewood, Colorado, United States, 80228
- DaVita Clinical Research
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- DaVita Clinical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Oral contraceptives are permitted for birth control.
- Acetaminophen (≤ 1 g/day) and low-dose ASA (i.e., ≤ 325 mg per day) are permitted.
- Currently receives hemodialysis or peritoneal dialysis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single dose of RPX7009 and RPX2014
Single dose of combination RPX7009 and RPX2014
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety from baseline through the end of the study
Time Frame: 7days
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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
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7days
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Collaborators and Investigators
Investigators
- Principal Investigator: Chris Galloway, MD, Da Vita Clinical Research
- Principal Investigator: Jolene K Berg, MD, Da Vita Clinical Research
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rempex 504
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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