Table 3.
Isavuconazole and BAL8728 pharmacokinetic parameters for participants with ESRD and healthy control group
| Parameter | Isavuconazole | BAL8728 | ||||
|---|---|---|---|---|---|---|
| Healthy control group (n = 8)a | ESRD day 1 (n = 8)b | ESRD day 15 (n = 8) | Healthy control group (n = 8)a | ESRD day 1 (n = 8)b | ESRD day 15 (n = 8) | |
| AUC72, mg*h/L | 36.9 ± 9.5 | 25.1 ± 10.0 | 32.3 ± 15.4 | 1.2 ± 0.4 | 1.3 ± 0.3 | 0.9 ± 0.2 |
| C max, mg/L | 4.6 ± 1.1 | 3.7 ± 1.3 | 3.7 ± 0.8 | 0.9 ± 0.2 | 0.9 ± 0.3 | 0.9 ± 0.2 |
| AUC∞, mg*h/L | 94.7 ± 32.3 | 95.7 ± 78.6 | – | 1.2 ± 0.4 | 1.3 ± 0.3 | – |
| AUClast, mg*h/L | 77.9 ± 22.1 | 62.0 ± 40.2 | – | 1.1 ± 0.3 | 1.2 ± 0.3 | – |
| t max, h | 1.0 (1.0–1.1) | 1.0 (1.0–1.0) | 1.0 (1.0–1.0) | 1.0 (1.0–1.1) | 1.0 (1.0–1.0) | 1.0 (1.0–1.0) |
| t ½, h | 125.5 ± 63.3 | 204.5 ± 82.6 | – | 1.3 ± 0.1 | 1.5 ± 0.3 | – |
| V z, L | 386.2 ± 150.5 | 735.6 ± 277.3 | – | 133.3 ± 35.2 | 144.3 ± 64.3 | – |
| CL, L/h | 2.4 ± 0.8 | 2.9 ± 1.3 | – | 70.5 ± 23.0 | 64.5 ± 23.9 | – |
| Aelast, % | 0.5 ± 0.2 | – | – | – | – | – |
| CLR, mL/h | 12.5 ± 5.5 | – | – | – | – | – |
| CLD, mL/h | – | 291.7 ± 87.4 | – | – | – | – |
All PK data expressed as mean ± standard deviation, except t max, which is expressed as median (range)
Ae last cumulative amount of unchanged isavuconazole excreted in the urine, AUC area under the concentration–time curve, AUC 72 AUC from time of dosing until 72 h, AUC ∞ AUC extrapolated to infinity, AUC last AUC to last measurable plasma concentration, C max maximum concentration of isavuconazole, CL total clearance of isavuconazole, CL D dialysis clearance of isavuconazole, CL R renal clearance of isavuconazole from plasma, ESRD end-stage renal disease, t max time to reach maximum concentration, t ½ half-life of isavuconazole
aOne participant discontinued on day 1
bPharmacokinetic results for three participants with ESRD were unavailable due to a handling error during sample collection resulting in the contamination of C max values