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

R

Rempex Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers
Bacterial Infections

Treatments

Drug: RPX7009
Drug: Normal saline
Drug: Biapenem

Study type

Interventional

Funder types

Industry

Identifiers

NCT01772836
Rempex 403

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 4 patient groups, including a placebo group

Normal saline
Placebo Comparator group
Description:
Single and multiple dose of normal saline
Treatment:
Drug: Normal saline
Single dose IV of biapenem or RPX7009
Experimental group
Description:
Single dose IV infusion of biapenem or RPX7009
Treatment:
Drug: Biapenem
Drug: RPX7009
Single dose of biapenem or RPX7009
Experimental group
Description:
Single IV dose of biapenem or RPX7009 (for those on active drug, this will be the drug not given in the first IV treatment)
Treatment:
Drug: Biapenem
Drug: RPX7009
Biapenem and RPX7009 in combination
Experimental group
Description:
Single dose followed by a multiple dose of biapenem and RPX7009 in combination
Treatment:
Drug: Biapenem
Drug: RPX7009

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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