TABLE 4.
Summary of RE104 Plasma PK Parameters by Dose (PK Evaluable Population)
| Plasma PK Parameters | RE104 Dose | |||||
|---|---|---|---|---|---|---|
| 5 mg (n=6) | 11 mg (n=6) | 20 mg (n=6) | 30 mg (n=9) | 35 mg (n=6) | 40 mg (n=3) | |
| Summary Statistics | ||||||
| Cmax (ng/mL) | 149.756 (63.0) | 491.960 (43.8) | 779.898 (15.9) | 1319.347 (47.2) | 1224.425 (20.1) | 1781.941 (19.9) |
| Tmax (h) | 0.500 (0.25-0.50) | 0.250 (0.25-0.50) | 0.375 (0.25-0.50) | 0.250 (0.12-0.50) | 0.375 (0.25-0.50) | 0.500 (0.25-0.50) |
| Tlast (h) | 4.000 (3.00-5.00) | 5.000 (4.00-6.00) | 5.000 (4.00-6.02) | 5.000 (4.00-5.15) | 5.542 (4.00-8.00) | 6.183 (6.02-8.00) |
| Tlag (h) | 0 | 0 | 0 | 0 | 0 | 0 |
| kel (1/h) | 1.391 (0.39340) | 1.485 (0.29261) | 1.459 (0.40487) | 1.641 (0.21051) | 1.248 (0.53208) | 1.329 (0.15708) |
| t½ (h) | 0.5315 (0.14595) | 0.4829 (0.10037) | 0.5046 (0.12989) | 0.4293 (0.061541) | 0.6437 (0.25484) | 0.5265 (0.063774) |
| AUC0-t (h*ng/mL) | 134.8 (64.9) | 433.2 (49.4) | 764.6 (16.7) | 978.2 (27.6) | 1187 (15.4) | 1814 (15.8) |
| AUC0-inf (h*ng/mL) | 135.6 (64.6) | 433.6 (49.3) | 765.3 (16.7) | 978.8 (27.6) | 1188 (15.5) | 1814 (15.8) |
| %AUCext (%) | 0.6066 (0.40628) | 0.1050 (0.036846) | 0.08935 (0.039773) | 0.06384 (0.026512) | 0.08987 (0.095418) | 0.03467 (0.019110) |
| Cmax/dose (ng/mL/mg) | 29.951 (63.0) | 49.196 (43.8) | 38.995 (15.9) | 43.978 (47.2) | 35.439 (20.1) | 44.549 (19.9) |
| AUC0-t/dose (h*ng/mL/mg) | 26.96 (64.9) | 43.32 (49.4) | 38.23 (16.7) | 32.61 (27.6) | 34.34 (15.4) | 45.35 (15.8) |
| AUC0-inf/dose (h*ng/mL/mg) | 27.13 (64.6) | 43.36 (49.3) | 38.26 (16.7) | 32.63 (27.6) | 34.37 (15.5) | 45.36 (15.8) |
| CL/F (L/h) | 41.76 (20.132) | 25.22 (11.553) | 26.42 (3.9805) | 31.69 (8.9501) | 29.37 (4.3424) | 22.22 (3.3857) |
| Vz/F (L) | 31.75 (19.195) | 16.58 (5.4335) | 19.36 (6.3849) | 19.93 (7.3932) | 26.60 (9.6718); 6 | 16.67 (0.65750); 3 |
AUCs, Cmax, and their dose-normalized transformations are presented as geometric mean (geometric CV%); n=number of observations.
Tmax, Tlast, and Tlag are presented as median (min-max); n=number of observations.