Evaluating the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Carbavance™ (RPX2014/RPX7009) in Healthy Adult Subjects

NCT02073812 | Completed Phase 1

• 1 other identifier: Rempex 503
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

RPX7009(beta-lactamase inhibitor) is being studied in combination with a carbapenem (RPX2014) to treat bacterial infections, including those due to multi-drug resistant bacteria.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics from baseline through the end of the study

  Assessment of plasma, ELF and AM concentrations of RPX2014 and RPX7009 after 3 doses of Carbavance

  2 days

Secondary Outcomes (1)

• IV Carbavance concentrations in lung fluid

  2 days

Study Arms (1)

Multiple dose of Carbavance (RPX7009/RPX2014)

EXPERIMENTAL

Multiple dose of Carbavance

Drug: RPX7009 and RPX2014

Interventions

RPX7009 and RPX2014 DRUG

The study is designed to enroll approximately 25 healthy subjects. The study will evaluate the plasma, epithelial lining fluid, and alveolar macrophage concentrations of Carbavance (RPX7009/RPX2014)

Multiple dose of Carbavance (RPX7009/RPX2014)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males and/or females, 18 to 55 years of age (inclusive) at the time of screening.
• Body mass index (BMI) ≥ 18.5 and ≤ 30 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive) at the time of screening.
• Medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, electrocardiograms (ECGs), physical examination) as deemed by the PI.
• Non-tobacco/nicotine-containing product users for a minimum of 6 months prior to Day 1.
• Voluntarily consent to participate in the study.

You may not qualify if:

• History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
• Positive urine drug/alcohol testing at screening (or Day -1).
• Positive testing for human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg).
• 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.).
• Clinically significant pulmonary or any other disease that prevents a subject from undergoing bronchoscopy with bronchopulmonary lavage.
• History of seizures (e.g., epilepsy), head injury or meningitis requiring ongoing anti-seizure medications.
• Use of any prescription medication (with the exception of hormonal contraceptives or hormone replacement therapy for females) within 14 days prior to Day 1.
• Participation in another investigational clinical trial within 30 days prior to Day 1.
• Females who are pregnant or lactating.
• Surgery within the past three months prior to Day 1 determined by the PI to be clinically relevant.
• Any acute illness including clinically significant infection within 30 days prior to Day 1.
• QTcF interval \>450 msec, or history of prolonged QT syndrome at screening (or Day 1).
• Calculated creatinine clearance less than 80 mL/min (Cockroft-Gault method) at screening.
• Subjects who have any clinically significant abnormalities on laboratory values at screening (or Day -1), including:

Sponsors & Collaborators

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

Study Sites (1)

Pulmonary Associates

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Interventions

RPX7009

Study Officials

• Mark Gotfried, MD

  Pulmonary Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 27, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 5, 2018

Record last verified: 2018-03

Locations

US (1)