Table 6.
Results of a pharmacokinetic substudy of the LTE
| PK Parameter | 4-Week Schedule(n = 14) | 8-Week Schedule(n = 12) |
|---|---|---|
| Cmax (μg/ml; geometric mean [CV%]) | 136.3 (20) | 124.6 (27) |
| AUC0–τ (μg · h per ml; geometric mean [CV%]) | 13,587.1 (27) | 10,106.5 (27) |
| AUC∞ (μg · h per ml; geometric mean [CV%]) | NR | 10,219.7 (28) |
| Tmax (h; median [min, max]) | 0.50 (0.48, 2.03) | 0.55 (0.50, 1.92) |
| t1/2 (h; mean [SD]) | NR | 196.6 (57.2) |
| CLT (ml/h per kg; mean [SD]) | NR | 0.51 (0.14) |
| VSS (L/kg; mean [SD]) | NR | 0.12 (0.03) |
| Cmin (μg/ml; mean [SD]) | 6.32 (2.83) | NR |
Steady-state PK parameters were calculated for patients in the 4-week schedule; single-dose PK parameters were calculated for patients in the 8-week schedule. AUC0–τ, area under the plasma concentration-time curve from time 0 to the last measurable concentration; AUC∞, area under the serum concentration-time curve from time 0 extrapolated to infinity; CLT, total body clearance; Cmax, maximum serum concentration; Cmin, trough serum concentration; NR, not reported; t1/2, serum half-life; Tmax, time of maximum observed serum concentration; VSS, volume of distribution at steady state.