Table 2.
Summary of Total Plasma GAA Activity Pharmacokinetic Parameters by Treatment
| Treatment | Cohort | Period | Cmaxa (nmol/hr/mL) | tmaxb (hr) | AUC0-ta (hr × nmol/hr/mL) | AUC0-∞a (hr × nmol/hr/mL) | AUC Ratioa | Terminal Half-Lifec (hr) |
|---|---|---|---|---|---|---|---|---|
| AA alone (n = 6) | 1 | 1 | 17,269 (25.6) | 4.7 (4–5) | 108,578 (24.1) | 110,388 (24.5) | — | 3.8 (12.7) |
| AA + 50 mg duvoglustat HCl (n = 6) | 1 | 2 | 20,539 (21.2) | 4.5 (4–6) | 159,994 (18.1) | 165,983 (19.1) | 1.5 (12.0) | 4.4 (16.9) |
| AA alone (n = 6) | 2 | 1 | 22,785 (18.1) | 4.0 (3–5) | 141,515 (27.9) | 144,056 (28.6) | — | 3.8 (17.7) |
| AA + 100 mg duvoglustat HCl (n = 6) | 2 | 2 | 28,607 (14.1) | 4.0 (3–6) | 226,198 (25.4) | 237,613 (27.6) | 1.7 (9.8) | 4.8 (14.2) |
| AA alone (n = 6) | 3 | 1 | 18,986 (19.5) | 4.0 (4–4) | 107,489 (21.7) | 108,862 (22.1) | — | 3.6 (13.7) |
| AA + 250 mg duvoglustat HCl (n = 6) | 3 | 2 | 22,651 (9.0) | 4.0 (4–4) | 201,044 (8.3) | 215,276 (9.5) | 2.0 (19.7) | 5.4 (26.0) |
| AA alone (n = 7) | 4 | 1 | 18,628 (34.6) | 4.0 (3–6) | 118,483 (43.1) | 120,604 (44.3) | — | 3.7 (19.9) |
| AA + 600 mg duvoglustat HCl (n = 7) | 4 | 2 | 22,505 (36.4) | 4.0 (3–6) | 228,413 (38.4) | 254,074 (42.0) | 2.1 (20.8) | 6.3 (22.8) |
a
Geometric mean (CV%).
b
Median (range).
c
Arithmetic mean (CV%).