Table 1.
Pharmacokinetic parameters for pigtail macaques dosed with subcutaneous LEN.
| Pharmacokinetic Parameter | 15 mg/kg LENa (N = 3) |
50 mg/kg LENa (N = 3) |
25 mg/kg LENb (N = 3) |
|||
|---|---|---|---|---|---|---|
| Mean ± SD | CV% | Mean ± SD | CV% | Mean ± SD | CV% | |
| AUClast (μM∗h) | 80.7 ± 2.5 | 3.1 | 408 ± 106 | 26.1 | 91.3 ± 17.8 | 19.5 |
| AUCinf (μM∗h) | 80.9 ± 2.5 | 3.1 | 408 ± 106 | 26.1 | 92.0 ± 17.8 | 19.3 |
| t1/2 (h) | 1010 ± 676 | 67.0 | 1160 ± 140 | 11.9 | 925 ± 342 | 36.9 |
| Cmax (nM) | 67.8 ± 10.1 | 14.9 | 295 ± 58 | 19.8 | 47.0 ± 5.7 | 12.1 |
| Tmax (h) | 1570 ± 84 | 5.4 | 1640 ± 69 | 4.2 | 1520 ± 898 | 59.1 |
Analytes include area under the plasma concentration-time curve from time 0 to the last quantifiable time point (AUClast), area under the plasma concentration-time curve from time 0 to infinity (AUCinf), maximal concentration (Cmax), time to reach observed peak plasma concentration (Tmax) and terminal half-life (t1/2), determined by non-compartmental analysis using Phoenix WinNonlin 6.4 build 8.1.03530.
CV, coefficient of variation (100 × standard deviation/mean).
a
Sequential subcutaneous LEN dosing to pigtail macaques on Study Day 0 and 42.
b
Single subcutaneous LEN dosing to pigtail macaques on Study Day 0.