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Pharmacology

Meropenem-RPX7009 Concentrations in Plasma, Epithelial Lining Fluid, and Alveolar Macrophages of Healthy Adult Subjects

Eric Wenzler, Mark H. Gotfried, Jeffrey S. Loutit, Stephanie Durso, David C. Griffith, Michael N. Dudley, Keith A. Rodvold
Eric Wenzler
aCollege of Pharmacy, University of Illinois at Chicago, Chicago, Illinois, USA
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Mark H. Gotfried
bPulmonary Associates, Phoenix, Arizona, USA
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Jeffrey S. Loutit
cThe Medicines Company, San Diego, California, USA
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Stephanie Durso
cThe Medicines Company, San Diego, California, USA
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David C. Griffith
cThe Medicines Company, San Diego, California, USA
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Michael N. Dudley
cThe Medicines Company, San Diego, California, USA
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Keith A. Rodvold
aCollege of Pharmacy, University of Illinois at Chicago, Chicago, Illinois, USA
dCollege of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA
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DOI: 10.1128/AAC.01713-15
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ABSTRACT

The steady-state concentrations of meropenem and the β-lactamase inhibitor RPX7009 in plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM) concentrations were obtained in 25 healthy, nonsmoking adult subjects. Subjects received a fixed combination of meropenem (2 g) and RPX7009 (2 g) administered every 8 h, as a 3-h intravenous infusion, for a total of three doses. A bronchoscopy and bronchoalveolar lavage were performed once in each subject at 1.5, 3.25, 4, 6, or 8 h after the start of the last infusion. Meropenem and RPX7009 achieved a similar time course and magnitude of concentrations in plasma and ELF. The mean pharmacokinetic parameters ± the standard deviations of meropenem and RPX7009 determined from serial plasma concentrations were as follows: Cmax = 58.2 ± 10.8 and 59.0 ± 8.4 μg/ml, Vss = 16.3 ± 2.6 and 17.6 ± 2.6 liters; CL = 11.1 ± 2.1 and 10.1 ± 1.9 liters/h, and t1/2 = 1.03 ± 0.15 and 1.27 ± 0.21 h, respectively. The intrapulmonary penetrations of meropenem and RPX7009 were ca. 63 and 53%, respectively, based on the area under the concentration-time curve from 0 to 8 h (AUC0–8) values of ELF and total plasma concentrations. When unbound plasma concentrations were considered, ELF penetrations were 65 and 79% for meropenem and RPX7009, respectively. Meropenem concentrations in AMs were below the quantitative limit of detection, whereas median concentrations of RPX7009 in AMs ranged from 2.35 to 6.94 μg/ml. The results from the present study lend support to exploring a fixed combination of meropenem (2 g) and RPX7009 (2 g) for the treatment of lower respiratory tract infections caused by meropenem-resistant Gram-negative pathogens susceptible to the combination of meropenem-RPX7009.

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Meropenem-RPX7009 Concentrations in Plasma, Epithelial Lining Fluid, and Alveolar Macrophages of Healthy Adult Subjects
Eric Wenzler, Mark H. Gotfried, Jeffrey S. Loutit, Stephanie Durso, David C. Griffith, Michael N. Dudley, Keith A. Rodvold
Antimicrobial Agents and Chemotherapy Nov 2015, 59 (12) 7232-7239; DOI: 10.1128/AAC.01713-15

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Meropenem-RPX7009 Concentrations in Plasma, Epithelial Lining Fluid, and Alveolar Macrophages of Healthy Adult Subjects
Eric Wenzler, Mark H. Gotfried, Jeffrey S. Loutit, Stephanie Durso, David C. Griffith, Michael N. Dudley, Keith A. Rodvold
Antimicrobial Agents and Chemotherapy Nov 2015, 59 (12) 7232-7239; DOI: 10.1128/AAC.01713-15
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