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

NCT ID: NCT01702649

Last Updated: 2012-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy Volunteers Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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RPX2003 (Biapenem)

Single and multiple dose of RPX2003 (Biapenem).

Group Type EXPERIMENTAL

RPX2003 (Biapenem)

Intervention Type DRUG

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.

Normal Saline

Single and multiple doses of normal saline.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeff Loutit, MBChB

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

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Celerion

Tempe, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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Rempex 401

Identifier Type: -

Identifier Source: org_study_id