Table 2

Plasma PK of verinurad in the presence of febuxostat 40 or 80 mg (geometric mean (95% CIs)) (PK population)

Febuxostat
(mg)
Verinurad
(mg)
Patient, nCmax (ng/mL)AUC0-24 (ng·h/mL)Tmax (h)t1/2 (h)*fe0-24 (%)
402.5123.45 (2.63 to 4.52)28.0 (21.2 to 36.9)3.50 (1.50 to 8.00)13.0 (8.89 to 19.1)0.661 (0.437 to 1.00)
5127.20 (5.55 to 9.34)62.2 (47.8 to 80.8)3.50 (2.00 to 6.00)13.2 (8.11 to 21.4)0.657 (0.444 to 0.970)
102415.5 (12.9 to 18.6)123 (104 to 146)3.00 (1.50 to 10.0)8.26 (6.71 to 10.2)0.810 (0.622 to 1.05)
152321.2 (18.0 to 25.1)186 (164 to 212)3.00 (1.50 to 8.00)10.6 (8.41 to 13.3)0.692 (0.561 to 0.853)
201126.1 (20.1 to 33.9)216 (173 to 270)3.00 (1.50 to 6.00)11.6 (7.17 to 18.8)0.717 (0.542 to 0.949)
802.5123.37 (2.42 to 4.68)27.4 (19.7 to 38.1)2.50 (1.00 to 10.0)12.5 (8.18 to 19.2)0.622 (0.347 to 1.11)
5127.54 (5.69 to 9.99)57.6†(46.8 to 70.9)4.00 (1.50 to 12.0)11.3† (7.09 to 18.1)0.640 (0.392 to 1.05)
101316.1 (12.6 to 20.6)138 (106 to 179)3.00 (1.00 to 12.0)9.64‡ (6.77 to 13.7)1.03 (0.710 to 1.49)
151120.4 (15.8 to 26.2)225 (182 to 278)4.00 (2.00 to 6.00)10.8 (8.17 to 14.3)0.816 (0.493 to 1.35)
  • Tmax values are presented as median (range).

  • *Terminal t1/2 values were calculated from a period of less than twofold of the calculated t1/2 value in more than half the subjects.

  • †n=11; AUC0-24, t1/2 in one subject were unreportable due to indeterminable terminal half-life.

  • ‡n=12; t1/2 in one subject was unreportable due to indeterminable terminal half-life.

  • AUC0-24, area under the concentration-time curve from time 0 up to 24  hours postdose; Cmax, maximum observed concentration; t1/2, plasma terminal half-life; Tmax, time of maximum observed plasma concentration.