Table 2.
Summary of pharmacokinetic parameters for MOD-4023 (±s.d.).
Parameter* | Cohort 2 weekly 37% molar content | Cohort 3 weekly 55.5% molar content | Cohort 1A weekly 123.4% molar content |
---|---|---|---|
Dose (mg) | 1.23 ± 0.57 | 1.29 ± 0.67 | 5.62 ± 3.11 |
Cmax (ng/mL) | 2.65 ± 2.77 | 4.06 ± 4.27 | 14.4 ± 14.71 |
Tmax (h) | 12 | 10 | 8 |
Cmin (ng/mL) | 0.038 ± 0.13 | 0.106 ± 0.24 | 0.638 ± 1.39 |
AUC(0−τ) (h × ng/mL) | 160 ± 186 | 245 ± 303 | 717 ± 813 |
Cavg (ng/mL) | 0.954 ± 1.11 | 1.46 ± 1.80 | 4.27 ± 4.84 |
Percent fluctuation | 289 ± 58.1 | 329 ± 82.2 | 343 ± 210 |
λz (1/h) | 0.0222 ± 0.0055 | 0.0217 ± 0.0054 | 0.0200 ± 0.0051 |
t1/2 (h) | 32.7 ± 6.42 | 34.0 ± 8.92 | 36.9 ± 9.92 |
CL/F (mL/h) | 13 570 ± 10 181 | 11 459 ± 7219 | 12 505 ± 6061 |
Vz/F (mL) | 674 904 ± 625 819 | 573 597 ± 463 706 | 671 468 ± 407 033 |
λz, terminal elimination rate; AUC, area under curve; CL/F, apparent total clearance; Cavg, average concentration; Cmax, maximal concentration; Cmin, minimal concentration; t1/2, half-life; Tmax, time of maximal concentration; Vz/F, apparent volume of distribution.