Safety Study of Intravenous Biapenem (RPX2003) and RPX7009 Given Alone and in Combination

NCT ID: NCT01772836

Last Updated: 2013-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-03-31

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.

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 and pharmacodynamics of Intravenous Biapenem and RPX7009, administered alone and in combination in healthy adult subjects.

Conditions

Healthy Volunteers; Bacterial Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Normal saline

Single and multiple dose of normal saline

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Single dose IV of biapenem or RPX7009

Single dose IV infusion of biapenem or RPX7009

Group Type: EXPERIMENTAL

RPX7009

Intervention Type: DRUG

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Biapenem

Intervention Type: DRUG

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Single dose of biapenem or RPX7009

Single IV dose of biapenem or RPX7009 (for those on active drug, this will be the drug not given in the first IV treatment)

Group Type: EXPERIMENTAL

RPX7009

Intervention Type: DRUG

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Biapenem

Intervention Type: DRUG

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Biapenem and RPX7009 in combination

Single dose followed by a multiple dose of biapenem and RPX7009 in combination

Group Type: EXPERIMENTAL

RPX7009

Intervention Type: DRUG

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Biapenem

Intervention Type: DRUG

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Interventions

RPX7009

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Intervention Type: DRUG

Biapenem

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Intervention Type: DRUG

Normal saline

Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)

Intervention Type: DRUG

Other Intervention Names

(beta-lactamase inhibitor); RPX2003; Placebo

Eligibility 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 beta-lactam antibiotics (e.g. penicillins, cephalosporins, carbapenems, etc.).
• 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rempex Pharmaceuticals (a wholly owned subsidiary of The Medicines Company)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jefferey Loutit, MBChB

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

CMAX

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

Rempex 403

Identifier Type: -

Identifier Source: org_study_id