Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rempex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01702649
First received: September 25, 2012
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

RPX2003 (biapenem) is being studied in combination with a beta-lactamase inhibitor to treat bacterial infections, including those due to multi-drug resistant bacteria.


Condition Intervention Phase
Healthy Volunteers
Bacterial Infections
Drug: RPX2003 (Biapenem)
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 RPX2003 in Healthy Adult Subjects

Resource links provided by NLM:


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 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 RPX2003 & placebo following single dose administration. [ Time Frame: Part 1A Study Day 1 to 3. ] [ Designated as safety issue: No ]
    plasma AUC0-t, AUC0-inf, Cmax, and Tmax.

  • Composite of PK parameters RPX2003 & placebo following multiple dose administration. [ Time Frame: Part 1B Day 4 to 12 ] [ Designated as safety issue: No ]
    plasma AUC0-t, AUC0-inf, Cmax, and Tmax.


Enrollment: 36
Study Start Date: August 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RPX2003 (Biapenem)
Single and multiple dose of RPX2003 (Biapenem).
Drug: RPX2003 (Biapenem)

Six (6) cohorts of 3 active or 8 subjects of 6 active are planned for evaluation.

Single dose followed by multiple dose, three times a day.

Placebo Comparator: Normal Saline
Single and multiple doses of normal saline.
Drug: Placebo

Six (6) cohorts of 1 placebo or 8 subjects of 2 placebo are planned for evaluation.

Single dose followed by multiple dose, three times a day.


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 biapenem, 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, 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.
  • Hypersensitivity or idiosyncratic reaction to compounds related to the study drug (e.g. beta-lactam antibiotics such as penicillins, carbapenems, etc).
  • History of seizures (e.g., epilepsy).
  • 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.
  • Blood donation or significant blood loss (i.e., > 500 mL) within 56 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: NCT01702649

Locations
United States, Arizona
Celerion
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Rempex Pharmaceuticals
Investigators
Study Director: Jeff Loutit, MBChB Sponsor GmbH
  More Information

No publications provided

Responsible Party: Rempex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01702649     History of Changes
Other Study ID Numbers: Rempex 401
Study First Received: September 25, 2012
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bacterial Infections
Biapenem
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014