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

This study is currently recruiting participants.
Verified February 2013 by Rempex Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Rempex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01751269
First received: December 13, 2012
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  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-Dose Study of the Safety, Tolerability, Pharmacokinetics of Intravenous RPX7009 in Healthy Adult Subjects.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rempex Pharmaceuticals:

Primary Outcome Measures:
  • Safety from baseline through the end of the study. [ Time Frame: Study Day 1 to Day 4. ] [ 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 3 ] [ Designated as safety issue: No ]
    Plasma AUC0-t, AUC0-inf, Cmax, and Tmax.


Estimated Enrollment: 48
Study Start Date: December 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ascending Single dose of RPX7009
Ascending Single dose of RPX7009
 Drug: RPX7009
Six (6) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.
Other Name: (beta-lactamase inhibitor)
Placebo Comparator: Normal Saline
Ascending Single dose of normal saline.
 Drug: Placebo
Six (6) 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 (RPX2003 or biapenem) 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751269

Contacts
Contact: Elizabeth Morgan 858-875-6671 lmorgan@rempexpharma.com
Contact: Jefferey Loutit, MBChB 858-875-6665 jloutit@rempexpharma.com

Locations
Australia, South Australia
CMAX Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Sepehr Shakib, MB, BS, (Hons) PhD FRACP     +61-8-8222-3923     sepehr.shakib@health.sa.gov.au    
Principal Investigator: Sepehr Shakib, MB, BS, (Hons) PhD FRACP            
Sponsors and Collaborators
Rempex Pharmaceuticals
Investigators
Study Director: Jefferey Loutit, MBChB Sponsor GmbH
  More Information

No publications provided

Responsible Party: Rempex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01751269     History of Changes
Other Study ID Numbers: Rempex 402
Study First Received: December 13, 2012
Last Updated: February 20, 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 May 16, 2013