Table 3.
PK parameter | Treatment | Geometric mean (adjusted) | 90% CI |
---|---|---|---|
Cmax (ng/mL) | D | 178 | (154, 205) |
F | 186 | (166, 209) | |
F vs D | 1.046 | (0.910, 1.202) | |
AUC(0-T) (ng h/mL) | D | 613 | (550, 683) |
F | 638 | (568, 717) | |
F vs D | 1.041 | (0.950, 1.139) | |
AUC(inf) (ng h/mL) | D | 625 | (563, 695) |
F | 654 | (583, 733) | |
F vs D | 1.045 | (0.954, 1.145) |
AUC (0-T) area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration, AUC (inf) area under the plasma concentration-time curve from time zero extrapolated to infinite time, CI confidence interval, C max maximum observed plasma concentration, PK pharmacokinetic. Treatments: D single-dose methotrexate 7.5 mg (day 1) + single-dose leucovorin 15 mg (day 2), F BMS-986142 350 mg QD (days 8 to 10) + single-dose methotrexate 7.5 mg (day 8) + single-dose leucovorin 15 mg (day 9)