Table 3.
Plasma Duvoglustat PK Summary and Dose Proportionality Analysis
| Duvoglustat HCl Dose (n) | Cmaxa (ng/mL) | tmaxb (hr) | AUC0–ta (hr × ng/mL) | AUC0–∞a (hr × ng/mL) | Terminal Half-Lifec (hr) |
|---|---|---|---|---|---|
| 50 mg (6) | 1060 (20.7) | 1.08 (0.98, 2.05) | 7,073 (24.0) | 7,122 (24.1) | 3.26 (6.0) |
| 100 mg (6) | 1870 (14.1) | 2.49 (2.00, 4.00) | 1 3,136 (20.8) | 1 3,271 (21.0) | 3.40 (9.9) |
| 250 mg (6) | 3150 (34.0) | 2.02 (1.97, 3.00) | 2 1,693 (18.1) | 2 2,010 (17.5) | 3.67 (14.4) |
| 600 mg (7) | 6050 (38.8) | 3.00 (2.00, 5.00) | 3 8,490 (40.9) | 3 9,068 (41.1) | 3.73 (9.9) |
| Beta (90% CI) | 0.69 (0.59, 0.78) | — | 0.66 (0.57, 0.76) | 0.67 (0.57, 0.76) | — |
a
Geometric mean (CV%).
b
Median (minimum, maximum).
c
Arithmetic mean (SD).