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CompletedNCT02073812Updated Mar 5, 2018

Evaluating the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Carbavance™ (RPX2014/RPX7009) in Healthy Adult Subjects

A Phase 1 interventional study of RPX7009 and RPX2014 in Healthy Subjects, sponsored by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company). Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-05.

Sponsored by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the 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 pharmacokinetics of intravenous RPX2014 and RPX7009 in plasma and epithelial fluid.

02

Conditions studied

  • Healthy Subjects
03

In context

Lead sponsor

Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company) is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy adult males and/or females, 18 to 55 years of age (inclusive) at the time of screening.
  2. Body mass index (BMI) ≥ 18.5 and ≤ 30 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive) at the time of screening.
  3. Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, electrocardiograms (ECGs), physical examination) as deemed by the PI.
  4. Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day 1.
  5. Voluntarily consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

  1. History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
  2. Positive urine drug/alcohol testing at screening (or Day -1).
  3. Positive testing for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg).
  4. History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
  5. Hypersensitivity or idiosyncratic reaction to beta-lactam antibiotics (e.g. penicillins, cephalosporins, carbapenems, etc.).
  6. Clinically significant pulmonary or any other disease that prevents a subject from undergoing bronchoscopy with bronchopulmonary lavage.
  7. History of seizures (e.g., epilepsy), head injury or meningitis requiring ongoing anti-seizure medications.
  8. Use of any prescription medication (with the exception of hormonal contraceptives or hormone replacement therapy for females) within 14 days prior to Day 1.
  9. Participation in another investigational clinical trial within 30 days prior to Day 1.
  10. Females who are pregnant or lactating.
  11. Surgery within the past three months prior to Day 1 determined by the PI to be clinically relevant.
  12. Any acute illness including clinically significant infection within 30 days prior to Day 1.
  13. QTcF interval >450 msec, or history of prolonged QT syndrome at screening (or Day 1).
  14. Calculated creatinine clearance less than 80 mL/min (Cockroft-Gault method) at screening.
  15. Subjects who have any clinically significant abnormalities on laboratory values at screening (or Day -1), including:

    1. White blood cell count (WBC) \< 3,000/mm3, hemoglobin \< 11g/dL.
    2. Absolute neutrophil count \< 1,200/mm3 or platelet count \< 120,000/mm3.
  16. Liver function abnormalities at screening (or Day -1) (defined by an elevation in bilirubin, AST or ALT 1.5 x ULN of the normal range for subjects based on age and sex).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Multiple dose of Carbavance (RPX7009/RPX2014)

    Multiple dose of Carbavance

    Drug: RPX7009 and RPX2014

Interventions

  • DrugRPX7009 and RPX2014

    The study is designed to enroll approximately 25 healthy subjects. The study will evaluate the plasma, epithelial lining fluid, and alveolar macrophage concentrations of Carbavance (RPX7009/RPX2014)

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What researchers measure

Primary outcomes

  1. Pharmacokinetics from baseline through the end of the study

    Assessment of plasma, ELF and AM concentrations of RPX2014 and RPX7009 after 3 doses of Carbavance

    Time frame: 2 days

Secondary outcomes

  1. IV Carbavance concentrations in lung fluid

    Plasma, ELF and AM concentrations of intravenous Carbavance in healthy adult subjects.

    Time frame: 2 days

07

Study locations

1 site
  • Pulmonary Associates
    Phoenix, Arizona 85006, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02073812
Lead sponsor
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
Responsible party
Sponsor
First posted
Feb 27, 2014
Start date
Feb 2014
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Mar 5, 2018

Study contacts

Mark Gotfried, MD
principal investigator · Pulmonary Associates

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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