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

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

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.

Key facts

Study ID

NCT02073812

Run by

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

People needed

26

Starts

2014-02-01

Expected to finish

2014-04-01

Last updated by the study team

2018-03-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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:
• White blood cell count (WBC) < 3,000/mm3, hemoglobin < 11g/dL.
• Absolute neutrophil count < 1,200/mm3 or platelet count < 120,000/mm3.
• Liver function abnormalities at screening (or Day -1) (defined by an elevation in bilirubin, AST or ALT 1.5 x ULN of the normal range for subjects based on age and sex).

Where it is running

• Pulmonary Associates — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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