Table 4. Pharmacokinetic parameters of JNJ-26483327 for days 1 and 28 (steady state).
| Doses (BID) | Day | Patients (n) | AUC (ng h ml−1) a | Cmax (ng ml−1) | tmax (h) | t1/2 (h) | CL/F (l h−1) | Vdz/F (l) |
|---|---|---|---|---|---|---|---|---|
| 800 mg | 1 | 3 | 10 621±5230 | 2210±593 | 2.03 (2.00–3.02) | 8.4±1.8 | 86.3±33.5 | 1021±401 |
| 28 | 2 | 10 623 | 2390 | 1.52 (1.00–2.03) | 76.4 | |||
| 1200 mg | 1 | 3 | 35 554±22 086 | 3707±1927 | 3.00 (2.00–6.00) | 5.2±1.7 | 47.4±35.3 | 342±212 |
| 28 | 2 | 21 230 | 2750 | 1.00 (1.00–1.00) | 88.4 | |||
| 1500 mg | 1 | 6 | 16 388±11 956 | 2361±1765 | 4.00 (2.00–4.03) | 4.8±0.5 | 144±104 | 1038±799 |
| 28 | 6 | 26 225±20 491 | 3375±2116 | 3.99 (3.00–12.00) | 286±540 | |||
| 2100 mg | 1 | 4a | 20 357±25 622 | 2213±2983 | 3.54 (2.00–4.08) | 6.7±1.7 | 3055±5099 | 36 985±62 264 |
| 28 | 2 | 8467 | 1236 | 5.00 (4.00–6.00) | 3087 |
tmax, median (min–max); Cmax, AUC, t1/2, CL/F, Vdz/F: mean±s.d. s.d.=standard deviation, given when data of >2 subjects.
AUCinf after the first dose and AUCtau at steady state (day 28).
a
n=3 for AUCinf, t1/2, CL/F and Vdz/F.