Table 1.
Pharmacokinetic parameters of venglustat after a single oral dose of 15 mg administration in healthy Chinese volunteers
| Parameter | Female volunteers (n = 7) | Male volunteers (n = 7) | All volunteers (N = 14) |
|---|---|---|---|
| Cmax (ng/mL) | |||
| Mean ± SD | 62.7 ± 20.7 | 57.9 ± 14.5 | 60.3 ± 17.3 |
| Geometric mean (CV) | 59.6 (33%) | 56.4 (25%) | 58.0 (29%) |
| tmax (h), median (range) | 3.00 (2.00–5.00) | 2.00 (1.00–3.00) | 2.50 (1.00–5.00) |
| tlast (h), median (range) | 120.00 (120.00–120.00) | 120.00 (120.00–120.00) | 120.00 (120.00–120.00) |
| AUC0–24 (ng·h/mL) | |||
| Mean ± SD | 950 ± 295 | 922 ± 208 | 936 ± 245 |
| Geometric mean (CV) | 909 (31%) | 904 (23%) | 906 (26%) |
| AUClast (ng·h/mL) | |||
| Mean ± SD | 1970 ± 708 | 2250 ± 506 | 2110 ± 610 |
| Geometric mean (CV) | 1860 (36%) | 2200 (22%) | 2020 (29%) |
| AUCinf (ng·h/mL) | |||
| Mean ± SD | 2040 ± 740 | 2530 ± 603 | 2280 ± 697 |
| Geometric mean (CV) | 1920 (36%) | 2460 (24%) | 2170 (31%) |
| t1/2z (h) | |||
| Mean ± SD | 24.6 ± 1.68 | 36.6 ± 5.71 | 30.6 ± 7.40 |
| Geometric mean (CV) | 24.6 (7%) | 36.2 (16%) | 29.8 (24%) |
| CL/F (L/h) | |||
| Mean ± SD | 8.29 ± 3.05 | 6.24 ± 1.47 | 7.27 ± 2.54 |
| Geometric mean (CV) | 7.82 (37%) | 6.09 (24%) | 6.90 (35%) |
| Vss/F (L) | |||
| Mean ± SD | 283 ± 88.3 | 318 ± 63.5 | 300 ± 76.1 |
| Geometric mean (CV) | 271 (31%) | 312 (20%) | 291 (25%) |
| MRT (h) | |||
| Mean ± SD | 34.8 ± 2.94 | 51.8 ± 8.54 | 43.3 ± 10.8 |
| Geometric mean (CV) | 34.7 (8%) | 51.2 (16%) | 42.2 (25%) |
AUC, area under the plasma concentration–time curve; AUCinf, AUC extrapolated to infinity; AUC0–24, AUC from time = 0 h to 24 h after drug administration; AUClast, AUC from time = 0 h to last measurable concentration; Cmax, maximum plasma concentration; CL/F, apparent systemic clearance from plasma; CV, coefficient of variation; Cmax, maximum concentration; h, hour; L, liter; mL, milliliter; MRT, mean residence time; ng, nanogram; SD, standard deviation; t1/2z, terminal half-life; tmax, time to Cmax; tlast, time of last measurable concentration; Vss/F, apparent volume of distribution at steady state