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Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT01751269
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : July 24, 2013
Sponsor:
Information provided by (Responsible Party):
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)

Brief Summary:
RPX7009 (beta-lactamase inhibitor) is being studies in combination with a carbapenem biapenem to treat bacterial infections, including those due to multi-drug resistant bacteria.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Bacterial Infections Drug: RPX7009 Drug: Placebo Phase 1

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 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 RPX7009, administered alone, in healthy adult subjects.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects.
Study Start Date : December 2012
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ascending Single and Multiple dose of RPX7009
Ascending Single and Multiple dose of RPX7009
Drug: RPX7009
Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.
Other Name: (beta-lactamase inhibitor)
Placebo Comparator: Normal Saline
Ascending Single and multiple dose of normal saline.
Drug: Placebo
Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.
Other Name: Normal saline



Primary Outcome Measures :
  1. Safety from baseline through the end of the study. [ Time Frame: Study Day 1 to Day 13. ]
    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.


Secondary Outcome Measures :
  1. Composite of PK parameters RPX7009 & placebo following single dose administration. [ Time Frame: Study Day 1 to Day 12 ]
    Plasma AUC0-t, AUC0-inf, Cmax, and Tmax.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult males and/or females (of Non Child-bearing potential), 18 to 55 years of age
  • Body mass index (BMI) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive).
  • Medically healthy with clinically insignificant screening results
  • Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day 1.
  • Sexually abstinent or use acceptable methods of birth control

Exclusion Criteria:

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
  • History or presence of alcoholism or drug abuse within the 2 years prior to Day 1.
  • Documented hypersensitivity reaction or anaphylaxis to any medication.
  • Use of any over-the-counter (OTC) medication, including herbal products and vitamins, within the 7 days prior to Day 1. Up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the PI.
  • Plasma donation within 7 days prior to Day 1.
  • Subjects who have any abnormalities on laboratory values at screening or check-in (Day -1).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751269


Locations
Australia, South Australia
CMAX
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
Investigators
Study Director: Jefferey Loutit, MBChB Sponsor GmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
ClinicalTrials.gov Identifier: NCT01751269     History of Changes
Other Study ID Numbers: Rempex 402
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: July 24, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Bacterial Infections
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents