Table 4.
PK cohort N = 16a |
|
---|---|
AUCtau (h·ng/mL) | |
n | 15 |
Mean (SD) | 2021 (1867.1) |
Median (range) | 1350 (463–6310) |
Cmax (ng/mL) | |
n | 16 |
Mean (SD) | 315.7 (298.02) |
Median (range) | 213.5 (45.0–1030) |
Tmax (h) | |
n | 16 |
Mean (SD) | 3.469 (2.1990) |
Median (range) | 2.965 (2.68–11.7) |
The lower limit of quantification was 0.200 ng/mL
AUCtau area under the concentration-time curve for a dosing interval, Cmax maximum concentration, PK pharmacokinetic, SD standard deviation, Tmax time required to reach maximum concentration
aTwo patients were excluded from the analysis as their post-dose PK profiles were not consistent with the known PK characteristics of crisaborole. Additionally, it was confirmed that they had venipuncture site–treatment area overlap and the study site did not follow venipuncture site cleaning procedures as specified in the protocol, potentially resulting in contamination of the PK samples