Table 2.
Pharmacokinetic parameters for voclosporin and ketoconazole after oral administration of voclosporin 0.4 mg kg−1 every 12 h alone and with ketoconazole 400 mg once daily
| Parameter | Voclosporin alone (n = 11) | Voclosporin + ketoconazole (n = 11) | |
|---|---|---|---|
| Voclosporin | Voclosporin | Ketoconazole | |
| Tmax (h) | 1.5 | 3.0 | 2.0 |
| Cmax (ng ml−1) | 97.0 ± 62.3 | 562 ± 125 | 12 258 ± 2928 |
| GMR % (90% CI) | – | 645 (502–829) | – |
| AUC(0–12) (h ng ml−1) | 304 ± 87 | 5513 ± 1358 | 108 428 ± 30 791 |
| GMR % (90% CI) | – | 1855 (1589–2165) | – |
Values are shown as means ± SD except for Tmax, for which the median is reported. Abbreviations are as follows: AUC, area under the curve; CI, confidence interval; Cmax, maximal concentration; GMR, geometric least squares mean ratio (comparison to voclosporin alone) based on analysis of natural log-transformed data; Tmax, time to reach maximal concentration.