Dose (mg) thalf (h) ± SD Cmax (ng/mL) ± SD Tmax (h) ± SD AUC(0-inf) (ng/mL) ± SD
SAD
0.3 mg (n=5)* 7.4 ± 3.1 15.3 ± 2.7 1.4 ± 1.1 117 ± 13.3
1 mg (n=4) 7.1 ± 0.9 43.7 ± 8.8 1.5 ± 0.4 351 ± 61.1
3 mg (n=4) 16.2 ± 8.6 136 ± 53.7 2.3 ± 1.2 1060 ± 307
10 mg (n=3) 9.0 ± 2.0 413 ± 221 0.7 ± 0.3 2660 ± 1830
30 mg (n=4) 8.9 ± 2.2 1520 ± 68.3 1.0 ± 0.0 11600 ± 1740
60 mg (n=6) 9.5 ± 0.7 2700 ± 4.0 0.9 ± 0.6 16100 ± 3840
100 mg (n=5) 10.0 ± 4.1 5110 ± 744 1.3 ± 1.0 35700 ± 6190
200 mg (n=5) 10.9 ± 1.6 6760 ± 1750 1.0 ± 0.4 43500 ± 14200
400 mg (n=6) 9.3 ± 1.0 12600 ± 3430 1.5 ± 0.8 85200 ± 16300
600 mg (n=6) 14.6 ± 12.7 14600 ± 4480 1.3 ± 0.6 96700 ± 17300
Food effect
100 mg, fasted (n=6) 12.6 ± 7.1 4490 ±949 1.6 ± 0.4 32900 ± 8060
100 mg, fed (n=6) 9.5 ± 0.6 3810 ± 967 3.3 ± 1.0 33300 ± 7430
Gender differences
100 mg, females (n=6) 15.1 ± 6.3 5390 ± 2140 1.3 ± 0.7 33100 ± 11800
100 mg, males (n=11) ** 11.4 ± 5.8 4774 ± 891 1.5 ± 0.7 31129 ± 11474
MAD
30 mg (n=8) 8.9 ± 1.8 1680 ± 380 1.0 ± 0.5 8000 ± 2060
70 mg (n=8) 13.6 ± 6.6 3000 ± 327 0.8 ± 0.4 14000 ± 1690
150 mg (n=8) 11.6 ± 2.6 5810 ± 1630 1.8 ± 0.6 33600 ± 12100