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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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  • FIG 1
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    FIG 1

    Mean (± the SD) concentration-versus-time profile of meropenem and RPX7009 in plasma (A) and epithelial lining fluid (B) before and after the third dose meropenem (2 g) and RPX7009 (2 g) administered as a 3-h i.v. infusion. In plate A, meropenem is illustrated by the filled circles and a solid line, and RPX7009 is illustrated by open circles and a dashed line. In plate B, meropenem is illustrated by the filled triangles and a solid line, and RPX7009 is illustrated by open triangles and a dashed line. Shaded region represents the 3-h infusion period. The y axis is in the log scale.

  • FIG 2
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    FIG 2

    Individual concentrations of meropenem in plasma (A; ●) and epithelial lining fluid (ELF) (B; ▲) and RPX7009 in plasma (C; ○) and ELF (D; △) at 1.5, 3.25, 4, 6, and 8 h after the third dose of meropenem (2 g) and RPX7009 (2 g) administered as a 3-h i.v. infusion. The shaded region represents the 3-h infusion period. Solid and dashed lines represent the median concentrations in plasma and ELF, respectively. The y axis is in the log scale.

  • FIG 3
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    FIG 3

    Individual concentrations of RPX7009 in alveolar macrophages (AM) (open squares) at 1.5, 3.25, 4, 6, and 8 h after the third dose of meropenem (2 g) and RPX7009 (2 g) administered as a 3-h i.v. infusion. The shaded region represents the 3-h infusion period. The solid line represents the median concentration in AM. The y axis is in the log scale.

  • FIG 4
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    FIG 4

    Mean (± the SD) plasma (● and ○; solid line) and epithelial lining fluid (ELF) (▲ and △; dashed lines) concentration-versus-time profiles of meropenem (A) and RPX7009 (B) at 1.5, 3.25, 4, 6, and 8 h after the third dose of meropenem (2 g) and RPX7009 (2 g) administered as a 3-h i.v. infusion. The shaded region represents the 3-h infusion period. The y axis is in the log scale.

Tables

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  • TABLE 1

    Characteristics of healthy adult subjects receiving meropenem and RPX7009

    Subject categoryNo. of male subjects (%)Mean ± SD
    Age (yr)Ht (cm)Wt (kg)CLCR (ml/min)aTotal cell count in BAL fluid (cells/mm3)Macrophages (%)
    All subjects (n = 25)18 (72)39.0 ± 10.6173.9 ± 9.580.3 ± 9.493.9 ± 22.8141.1 ± 100.885.4 ± 9.2
    BAL sampling time (h)b
        1.55 (100)32.2 ± 8.9180.9 ± 7.083.2 ± 5.5113.1 ± 12.5113.6 ± 46.389.4 ± 7.0
        3.253 (60)39.6 ± 11.5173.6 ± 10.380.5 ± 11.986.5 ± 15.192.2 ± 52.382.6 ± 13.1
        45 (100)40.4 ± 9.4178.6 ± 10.180.8 ± 13105.7 ± 34.8172.6 ± 80.491.0 ± 4.0
        63 (60)43.0 ± 12.4168.5 ± 9.180.9 ± 8.384.8 ± 19.5197.2 ± 186.179.6 ± 9.7
        82 (40)39.8 ± 11.8168.1 ± 5.276.2 ± 9.279.3 ± 8.9129.8 ± 76.084.6 ± 7.9
    • ↵a CLCR, calculated creatinine clearance.

    • ↵b n = 5 at each bronchoalveolar lavage (BAL) sampling time.

  • TABLE 2

    Pharmacokinetic parameters of meropenem (2 g) and RPX (2 g) in plasma infused over 3 h

    TreatmentMean ± SD
    Cmax (μg/ml)AUC0–8 (μg·h/ml)Vss (liters)CL (liters/h)t1/2 (h)
    Meropenem58.2 ± 10.8186 ± 33.616.3 ± 2.611.1 ± 2.11.03 ± 0.15
    RPX700959.0 ± 8.4204 ± 34.617.6 ± 2.610.1 ± 1.91.27 ± 0.21
  • TABLE 3

    Meropenem concentrations in plasma (total), epithelial lining fluid, and alveolar macrophages at sampling time of bronchoscopy and bronchoalveolar lavagea

    BAL sampling time (h)Mean concn (μg/ml) ± SD of meropenem in:
    Total plasmaELFAM
    1.541.2 ± 5.0221.4 ± 3.96BQL
    3.2547.7 ± 7.2828.3 ± 6.69BQL
    423.8 ± 4.3016.1 ± 4.77BQL
    67.24 ± 2.797.51 ± 5.29BQL
    81.36 ± 0.512.51 ± 1.13BQL
    • ↵a ELF, epithelial lining fluid; AM, alveolar macrophages; BAL, bronchoalveolar lavage; BQL, below the quantitative limit of detection (0.01 μg/ml).

  • TABLE 4

    RPX7009 concentrations in plasma (total), epithelial lining fluid, and alveolar macrophages at sampling time of bronchoscopy and bronchoalveolar lavagea

    BAL sampling time (h)Mean concn ± SD or median concn (range) of RPX7009 in μg/ml in:
    Total plasmaELFAM
    1.542.1 ± 5.0018.6 ± 3.762.28 (1.29–4.69)
    3.2551.1 ± 6.7826.1 ± 7.124.68 (2.08–25.1)
    428.2 ± 5.3215.7 ± 3.366.94 (1.26–8.36)
    610.8 ± 2.828.04 ± 5.813.85 (2.32–95.9)
    82.74 ± 1.122.61 ± 1.352.35 (2.22–11.7)
    • ↵a ELF, epithelial lining fluid; AM, alveolar macrophages; BAL, bronchoalveolar lavage.

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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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