TABLE 4.
Pharmacokinetic parameters of BAY 2433334 in plasma and urine on day 1 in Parts A and B of the study. Data are presented as geometric mean/geometric coefficient of variation (%), unless otherwise indicated
| BAY 2433334 25 mg OD n = 9 | BAY 2433334 50 mg OD n = 9 | BAY 2433334 100 mg OD n = 9 | BAY 2433334 25 mg BID n = 9 | |
|---|---|---|---|---|
| AUC (μg h L−1) | 6560/21.0 | 13 400/27.2 | 27 200/28.8 | 6120/25.5 |
| AUC/D (h L−1) | 0.263/21.0 | 0.268/27.2 | 0.272/28.8 | 0.245/25.5 |
| Cmax (μg L−1) | 358/23.6 | 675/25.7 | 1230/23.9 | 341/13.7 |
| Cmax/D (10−3 L−1) | 14.3/23.6 | 13.5/25.7 | 12.3/23.9 | 13.6/13.7 |
| tmax a (h) | 2.00 (1.48–5.98) | 2.00 (0.750–4.00) | 3.97 (1.47–6.00) | 3.00 (1.00–5.98) |
| t1/2 (h) | 14.0/15.0 | 15.9/13.6 | 15.8/18.6 | 14.6/23.5 |
| %AE,ur b (%) | – | 9.10/1.77 | 7.61/3.61 | 13.4/13.4 |
| CLR (L h−1) | – | 0.361/24.5 | 0.267/64.2 | 0.440/67.4 |
%AE,ur, percentage amount of drug excreted in urine; AUC, area under the plasma concentration–time curve; AUC/D, area under the plasma concentration–time curve divided by dose; BID, twice daily; CLR, renal clearance; Cmax, maximum plasma concentration; Cmax/D, maximum plasma concentration divided by dose; OD, once daily; t1/2, terminal half‐life; tmax, time to Cmax.
a
Median (range).
b
Arithmetic mean/standard deviation.