Table 2.
Tmax, hra | Cmax, ng/mL | AUC0‐24, ng·h/mL | Ae0‐24, μg | CLR0‐24, mL/min | |
---|---|---|---|---|---|
Verinurad | |||||
VERU 10 mg | 3.00 (1.50‐4.00) | 14.6 (12.2‐17.5) | 120 (98.1‐147) | 66.8 (51.8‐86.1) | 9.28 (7.43‐11.6) |
VERU 10 mg + ALLO 300 mg | 3.00 (2.00‐10.00) | 14.5 (11.7‐17.9) | 115 (96.5‐137) | 67.2 (51.7‐87.4) | 9.75 (7.73‐12.3) |
GMRb, % (90% CI) | − | 98.7 (87.7‐111) | 95.9 (88.4‐104) | 101 (86.7‐117) | 105 (94.4‐117) |
Allopurinol | |||||
Tmax, hra | Cmax, μg/mL | AUC0‐24, μg·h/mL | Ae0‐24, mg | CLR0‐24, mL/min | |
ALLO 300 mg | 1.50 (1.00‐4.00) | 1.13 (0.89‐1.43) | 3.69 (3.24‐4.21) | 25.4 (22.1‐29.2) | 120 (106‐135) |
VERU 10 mg + ALLO 300 mg | 1.25 (0.50‐4.00) | 1.51 (1.24‐1.82) | 3.68 (3.28‐4.13) | 22.7 (19.2‐26.9) | 103 (87.1‐122) |
GMRb, % (90% CI) | − | 133 (111‐159) | 102 (93.3‐111) | 89.5 (81.8‐98.0) | 87.5 (79.3‐96.6) |
Oxypurinol | |||||
Tmax, hra | Cmax, μg/mL | AUC0‐24, μg·h/mL | Ae0‐24, mg | CLR0‐24, mL/min | |
ALLO 300 mg | 4.00 (1.50‐6.00) | 12.8 (11.7‐14.0) | 255 (229‐284) | 231 (216‐248) | 15.1 (13.0‐17.6) |
VERU 10 mg + ALLO 300 mg | 3.50 (1.50‐8.00) | 8.68 (7.99‐9.43) | 157 (140‐177) | 275 (262‐290) | 29.2 (25.1‐33.9) |
GMRb, % (90% CI) | − | 67.9 (65.2‐70.7) | 61.8 (58.1‐65.7) | 119 (114‐125) | 193 (177‐210) |
Colchicine | |||||
Tmax, hra | Cmax, ng/mL | AUC0‐24, ng·h/mL | Ae0‐24, μg | CLR0‐24, mL/min | |
VERU 10 mg | 1.75 (1.00‐4.00) | 2.32 (1.93‐2.78) | 17.0 (14.3‐20.1) | − | − |
VERU 10 mg + ALLO 300 mg | 2.00 (1.00‐3.00) | 2.55 (2.17‐3.01) | 18.4 (15.6‐21.8) | − | − |
GMRb, % (90% CI) | − | 110 (101‐120) | 109 (99.8‐119) | − | − |
Ae0–24 indicates urinary excretion from time zero to 24 hours postdose; ALLO, allopurinol; AUC0–24, area under the concentration‐time curve from time 0 to 24 hours postdose; Cmax, maximum observed concentration; PK, pharmacokinetics; Tmax, time of maximum observed concentration; VERU, verinurad.
Data are geometric least squares mean (95% CI).
aTmax, median (range).
bGeometric least squares mean ratio (combo/alone).