TABLE 3.
Summary of plasma and urine pharmacokinetic parameters by renal function group following a single 9 mg oral dose of epaminurad under fasted conditions (study 1).
| Group 1 (n = 12) a | Group 2 (n = 9) | Group 3 (n = 6) | |
|---|---|---|---|
| AUC0‐t (h*ng/mL) | 6202.39 ± 1318.59 | 5345.08 ± 1477.38 | 6235.49 ± 779.16 |
| C max (ng/mL) | 775.09 ± 103.32 | 733.20 ± 170.70 | 794.45 ± 69.25 |
| T max (h) | 1.00 [0.50–2.50] | 1.00 [0.50–4.00] | 0.50 [0.50–1.00] |
| t 1/2 (h) | 7.26 ± 1.01 | 6.40 ± 1.35 | 7.98 ± 1.40 |
| Vd/F (L) | 15.52 ± 3.09 | 16.44 ± 4.72 | 16.80 ± 4.10 |
| CL/F (L/h) | 1.50 ± 0.34 | 1.85 ± 0.74 | 1.45 ± 0.17 |
| fet (%) | 0.36 ± 0.07 | 0.20 ± 0.04 | 0.19 ± 0.12 |
| Aet (mg) | 0.03 ± 0.01 | 0.02 ± − | 0.02 ± 0.01 |
| CLR (mL/h) | 5.57 ± 1.99 | 3.70 ± 1.52 | 2.79 ± 1.72 |
Note: Data presented as mean ± standard deviation, except for T max, which is presented as median [min—max].
Abbreviations: Aet, cumulative amount of urinary excretion up to the last time point of urine sampling; AUC0‐t, area under the curve; CL/F, apparent total clearance; CLR, renal clearance of the drug from plasma; C max, maximum plasma concentration; fet, fraction of the administered drug excreted into the urine; t 1/2, terminal elimination half‐life; T max, time to reach maximum plasma concentration; Vd/F, apparent volume of distribution.
fet, Aet, CLR were measured in 11 participants.