Table 2.
Vedolizumab pharmacokinetic parameters after a single intravenous infusion (180–750 mg) in healthy volunteers
| Parameter | Vedolizumab dosea | ||||
|---|---|---|---|---|---|
| Study 1: 180 mg (n = 11b) | Study 2: 300 mg (n = 8b,c) | Study 3: 450 mg (n = 13b) | Study 2: 600 mg (n = 22b,d) | Study 4: 750 mg (n = 64b,e) | |
| C max (µg/mL) | 48.2 (13.0) | 115 (31.1) | 188 (12.6) | 206 (23.7) | 239 (18.6) |
| AUC0−tlast (µg·day/mL) | 884 (19.0) | 1990 (13.5) | – | 3750 (22.9) | 5488 (23.3) |
| AUC0−∞ (µg·day/mL) | 899 (18.0) | 2000 (13.2) | – | 3890 (20.7) | 5813 (20.2) |
| t ½ (day) | 14.3 (20.0) | 18.3 (22.1) | – | 21.0 (20.9) | 26.2 (16.9) |
| CL (L/day) | 0.200 (25.5) | 0.150 (12.2) | – | 0.154 (19.7) | – |
| V z (L) | 4.05 (33.1) | 3.87 (18.9) | – | 4.57 (27.8) | – |
| V ss (L) | 5.72 (14.8) | 4.49 (14.3) | – | 4.95 (20.9) | – |
AUC 0−∞ area under the serum concentration–time curve from time zero to infinity, AUC 0−tlast area under the serum concentration–time curve from time zero to time of the last quantifiable concentration, CL total clearance, C max maximum observed serum concentration, t ½ β terminal elimination half-life, V ss volume of distribution at steady state, V z volume of distribution during the terminal phase, %CV percent coefficient of variation, – not determined
aValues are presented as geometric mean (%CV) for all parameters except t ½, which is presented as arithmetic mean (%CV)
bNumber of participants included in the pharmacokinetic analysis
c n = 10 for C max
d n = 24 for C max
e n = 62 for AUC0−∞ and t ½