Table 4.
Single Dose |
Steady State |
||
---|---|---|---|
FSGS | RA | FSGS | |
Tmax (hr) | 55±62a | 130±55& | 34.2±9.8 |
Cmax (μg/mL)# | 9.2±4.1a | 13.7±2.7 | 12.8±8.3 |
T½ (hr) | 159±155b | 389±71 | 273±402 |
AUC (μg hr/mL)# | 1649±1202b | 3622±587 | 2019±1693 |
Cl/F (mL/hr)+ | 20.2±8.4b,c | 11.2±2.0 | 53.2±43.3 |
Vd/z (L) | 3.5±1.3b | 5.7±0.9 | 6.6±5.4 |
Note: Data are provided as mean±SD. FSGS data are from the FONT study, rheumatoid arthritis (RA) values are from a previous study. 21
AUC data at single dose is 0-∞ and at steady state is 0-360 hours (represents a dosing interval)
Investigator Brochure cited in ref 21
normalized to a 40 mg dose
body weight scaled to a power of 0.75 (ref 21)
P<0.02 comparing FSGS single dose and RA single dose
P<0.001 comparing FSGS single dose and RA single dose
P<0.05 comparing FSGS single dose and FSGS steady state