TABLE 2.
Summary of pharmacokinetic parameters by renal group (nondialysis groups)a
| Renal impairment |
||||
|---|---|---|---|---|
| Parameter, unitb | Normal (n = 8) |
Mild (n = 6) |
Moderate (n = 6) |
Severe (n = 6) |
| Cefepimec | ||||
| Cmax, μg/mL | 102 (25.3) | 101 (19.4) | 124 (20.6) | 129 (21.8) |
| AUCinf, h·μg/mL | 343 (13.2) | 418 (9.0) | 913 (20.0) | 1589 (69.0) |
| t1/2, h | 2.53 (0.53) | 3.03 (0.39) | 5.53 (1.34) | 10.12 (5.16) |
| VZ, L | 20.2 (20.5) | 20.0 (21.2) | 16.3 (25.6) | 16.4 (21.1) |
| CL, L/h | 5.65 (13.8) | 4.61 (11.6) | 2.09 (23.2) | 1.23 (66.6) |
| Taniborbactam | ||||
| Cmax, μg/mL | 22.0 (11.2) | 22.8 (22.6) | 26.9 (24.1) | 27.9 (21.7) |
| AUCinf, h·μg/mL | 83.6 (11.4) | 97.4 (11.5) | 225 (22.5) | 445 (79.3) |
| t1/2, h | 10.2 (2.6) | 19.5 (9.9) | 17.6 (2.6) | 21.3 (10.1) |
| VZ, L | 82.0 (33.4) | 123.0 (59.5) | 53.1 (35.6) | 31.5 (43.5) |
| CL, L/h | 5.79 (11.7) | 4.95 (13.9) | 2.12 (25.8) | 1.10 (76.7) |
| CLR, L/h | 4.37 (17.8)d | 4.23 (22.7) | 1.59 (21.0) | 0.76 (120.3) |
a
Cmax = maximum plasma concentration; AUCinf = area under the plasma concentration versus time curve, extrapolated through infinity; t1/2 = terminal elimination half-life; Vz = volume of distribution estimated using the terminal phase; CL = total body clearance; CLR = renal clearance.
b
Geometric mean (geometric coefficient of variation [%]) shown for all parameters except for t1/2, which shows the mean (standard deviation).
c
Cefepime was not assayed in urine, and cefepime CLR was not estimated in study.
d
n = 7, as a subject was excluded from the summary statistics because of a missed urine collection.