Table 3.
Summary of serum PK parameters of part I (single dose)
| Dose (mg), condition | No. of subjectsa | AUC0–24 (ng · h/ml) | Cmax (ng/ml) | Tmax (h) |
|---|---|---|---|---|
| 25, fed | 0 | NAb | NA | NA |
| 100, fed | 1 | 3.09 (NA)c | 0.62 (NA) | 6.00 (NA) |
| 400, fed | 4 | 2.93 (2.89–2.97) | 0.59 (0.58–0.59) | 6.00 (6.00–6.03) |
| 400, fasted | 6 | 13.11 (6.55–35.6) | 2.24 (0.90–3.17) | 2.00 (2.00–6.00) |
| 1,000, fed | 5 | 3.81 (2.53–5.41) | 0.54 (0.51–0.76) | 6.02 (6.00–12.00) |
a
Number of subjects with adequate serum drug concentrations to evaluate AUC0–24 and Cmax.
b
NA, not available because of lack of measurable drug concentration data.
c
Data are presented as median (range).