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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)
ClinicalTrials.gov Identifier:
NCT01751269
First received: December 13, 2012
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Healthy Volunteers
Bacterial Infections
Drug: RPX7009
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company):

Primary Outcome Measures:
  • Safety from baseline through the end of the study. [ Time Frame: Study Day 1 to Day 13. ] [ Designated as safety issue: No ]
    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:
  • Composite of PK parameters RPX7009 & placebo following single dose administration. [ Time Frame: Study Day 1 to Day 12 ] [ Designated as safety issue: No ]
    Plasma AUC0-t, AUC0-inf, Cmax, and Tmax.


Enrollment: 80
Study Start Date: December 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 13, 2012
Last Updated: July 22, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Food and Drug Administration

Additional relevant MeSH terms:
Bacterial Infections

ClinicalTrials.gov processed this record on September 30, 2014