Table 1.
PK Parameters of ZYIL1 in Single‐Ascending‐Dose Study
| PK Parameters | 25 mg (N = 6 a ) | 50 mg (N = 6) | 100 mg (N = 6) | 250 mg (N = 6) | 400 mg (N = 6) |
|---|---|---|---|---|---|
| tmax (h) | 1.5 (0.5, 2) | 1 (0.5, 2) | 1 (0.5, 1.5) | 1 (0.5, 1) | 1 (1, 1) |
| Cmax (μg/mL) | 3.2 (0.8) | 5.7 (0.5) | 11.5 (1) | 30.4 (3.8) | 45.1 (4.8) |
| AUC0–t (μg • h/mL) | 27 (0.4) | 40.8 (7.2) | 92.3 (14.9) | 245 (64.8) | 340.9 (30.6) |
| AUC0–inf (μg • h/mL) | 27.1 (0.4) | 41.4 (6.6) | 92.8 (15.3) | 247.1 (66.5) | 341.8 (30.8) |
| t1/2 (hour) | 6.5 (0.7) | 5.8 (0.5) | 6.3 (0.7) | 6.5 (1.5) | 5.7 (0.5) |
| CL/F (L/h) | 0.9 (0) | 1.2 (0.2) | 1.1 (0.2) | 1.1 (0.3) | 1.2 (0.1) |
| Amount recovered (mg) | 21.2 (7.7) | 34.6 (6.2) | 76.6 (19.5) | 172.7 (20.7) | 201.3 (109.5) |
| Percent recovered (%) | 84.8 (30.7) | 69.1 (12.3) | 76.6 (19.5) | 69.1 (8.3) | 50.3 (27.3) |
AUC0–inf, area under the concentration–time curve from time 0 to infinity; AUC0–t, area under the curve concentration–time curve from time 0 to the time of the last measurable concentration; CL/F, clearance rate; Cmax, maximum observed plasma concentration; PK, pharmacokinetic; SD, standard deviation; t1/2, terminal elimination half‐life; tmax, time to maximum plasma concentration.
Data are expressed as mean (SD), except for tmax, which is shown as median (min, max).
a
N = 6 for Cmax, tmax, amount recovered and percent recovered while for the rest of the PK parameters, N = 5.