Table 2.
Mean (%CV) SBECD Pharmacokinetic Parameters Following IV Administration of 2400 mg SBECD Alone or With 300 mg Delafloxacin
| Plasma Pharmacokinetics | ||||||||
|---|---|---|---|---|---|---|---|---|
| Normal | Mild Impairment | Moderate Impairment | Severe Impairment | |||||
| Dose | Delafloxacin 300 mg IV | Placebo IV | Delafloxacin 300 mg IV | Placebo IV | Delafloxacin 300 mg IV | Placebo IV | Delafloxacin 300 mg IV* | Placebo IV |
| Cmax (μg/mL) | 177 (14.0) | 174 (14.9) | 167 (10.1) | 160 (10.5) | 191 (26.9) | 181 (20.9) | 197 (35.9) | 191 (19.8) |
| t½ (h) | 1.8 (8.5) | 1.7 (9.6) | 2.5 (33.0) | 2.4 (26.6) | 4.0 (19.3) | 4.0 (18.8) | 10.8 (25.9) | 9.7 (30.6) |
| AUC0‐t (μg·hr/mL) | 375 (11.9) | 359 (13.6) | 493 (31.8) | 427 (20.1) | 816 (26.5) | 760 (27.3) | 2010 (32.2) | 1878 (38.9) |
| AUC0‐∞ (μg·hr/mL) | 387 (11.6) | 371 (13.2) | 508 (31.5) | 446 (23.1) | 852 (25.4) | 802 (25.8) | 2130 (32.7) | 1989 (40.4) |
| CL (L/h) | 6.28 (12.5) | 6.57 (13.1) | 5.08 (26.0) | 5.60 (20.0) | 3.00 (27.3) | 3.15 (23.2) | 1.24 (32.7) | 1.38 (36.2) |
| Vss (L) | 12.8 (14.3) | 12.8 (14.8) | 14.4 (12.5) | 15.3 (15.2) | 15.0 (30.1) | 15.7 (26.5) | 16.4 (24.2) | 16.3 (18.2) |
| Urine pharmacokinetics | ||||||||
| Ae0‐48 (mg) | 1970 (8.7) | 1932 (19.4) | 2152 (24.5) | 2983 (100) | 2250 (21.3) | 2026 (23.4) | 1994 (23.8) | 1857 (19.6) |
| Fe0‐48 (%) | 82.1 (8.7) | 80.5 (19.4) | 89.7 (24.5) | 124 (100) | 93.8 (21.3) | 84.4 (23.4) | 83.1 (23.8) | 77.4 (19.6) |
| CLr (L/h) | 5.36 (18.9) | 5.43 (20.4) | 4.65 (36.4) | 6.54 (78.5) | 2.91 (29.7) | 2.87 (36.2) | 1.14 (47.7) | 1.13 (44.7) |
Ae indicates amount excreted; AUC, area under concentration‐time curve; CL, clearance; Cmax, peak concentration; %CV, coefficient of variation; Fe, fraction excreted; IV, intravenous; SBECD, sulfobutylether‐β‐cyclodextrin; t½, half‐time of elimination; Vss, volume of distribution at steady state.