Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02073812
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)

Tracking Information
First Submitted Date  ICMJE February 14, 2014
First Posted Date  ICMJE February 27, 2014
Last Update Posted Date March 5, 2018
Study Start Date  ICMJE February 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2014)
Pharmacokinetics from baseline through the end of the study [ Time Frame: 2 days ]
Assessment of plasma, ELF and AM concentrations of RPX2014 and RPX7009 after 3 doses of Carbavance
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2014)
IV Carbavance concentrations in lung fluid [ Time Frame: 2 days ]
Plasma, ELF and AM concentrations of intravenous Carbavance in healthy adult subjects.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Carbavance™ (RPX2014/RPX7009) in Healthy Adult Subjects
Official Title  ICMJE A Phase 1, Randomized, Open-Label, Trial Evaluating the Plasma, Epithelial Lining Fluid, and Alveolar Macrophage Concentrations of Intravenous Carbavance™ (RPX2014/RPX7009) in Healthy Adult Subjects
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Subjects
Intervention  ICMJE Drug: RPX7009 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)
Study Arms  ICMJE Experimental: Multiple dose of Carbavance (RPX7009/RPX2014)
Multiple dose of Carbavance
Intervention: Drug: RPX7009 and RPX2014
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2014)
26
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2014)
25
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02073812
Other Study ID Numbers  ICMJE Rempex 503
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
Study Sponsor  ICMJE Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Gotfried, MD Pulmonary Associates
PRS Account Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP