TABLE 5.
Values of PK parameters for VEL after single and multiple dosesa
| VEL dose (mg) | Single dose |
Multiple doses |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AUClast (ng · h/ml) | AUCinf (ng · h/ml) | Cmax (ng/ml) | C24 (ng/ml) | Tmax (h) | t1/2 (h) | CL/F (ml/h) | AUCtau (ng · h/ml) | Cmax (ng/ml) | Ctau (ng/ml) | Tmax (h) | t1/2 (h) | CLss/F (ml/h) | |
| 5 (n = 12) | 134 (69.6) | 159 (64.0) | 22.4 (55.4) | 1.3 (112)b | 1.50 (1.50, 2.00) | 11.2 (5.40, 16.9) | 58,400 (124) | 172 (51.7) | 28.3 (49.3) | 2.2 (76.0)c | 2.00 (1.25, 2.50) | 13.7 (13.2, 15.9) | 36,100 (46.4) |
| 50 (n = 12) | 2,970 (40.1) | 3,020 (40.1) | 371 (32.7) | 27.0 (45.1) | 2.50 (2.00, 3.00) | 13.6 (10.6, 16.5) | 19,200 (39.2) | 3,030 (40.4) | 411 (40.7) | 37.9 (59.5) | 2.50 (2.25, 3.00) | 13.0 (11.4, 16.2) | 19,600 (50.5) |
| 100 (n = 24) | 4,990 (44.8) | 5,060 (45.3) | 575 (37.2) | 47.2 (51.6) | 2.50 (2.50, 3.00) | 15.7 (12.6, 17.1) | 24,600 (50.8) | ||||||
| 150 (n = 12) | 4,930 (48.0) | 4,980 (47.8) | 608 (46.7) | 42.8 (46.5) | 2.75 (2.50, 3.50) | 16.2 (14.6, 17.6) | 72,200 (196) | 4,890 (45.4) | 669 (48.1) | 63.4 (42.8) | 2.50 (2.50, 3.50) | 15.2 (12.0, 15.6) | 45,100 (88.3) |
| 450 (n = 12) | 9,500 (34.5) | 9,580 (34.3) | 1,120 (31.7) | 87.5 (37.9) | 3.25 (25.0, 3.75) | 15.0 (12.9, 16.7) | 53,700 (42.5) | 9,510 (40.9) | 1,200 (38.0) | 128 (44.3) | 3.00 (2.50, 4.25) | 11.7 (10.6, 13.1) | 58,800 (57.3) |
a
All PK parameters are reported as mean (range of the percent coefficient of variation), except for Tmax and t1/2, which are reported as median (quartile 1, quartile 3). Data are for the number of subjects (n) indicated in the first column, unless indicated otherwise.
b
n = 7.
c
n = 10.