TABLE 2

Summary statistics of BMS-823778 PK parameters on days 1 and 14 in healthy subjects after daily doses of BMS-823778 for 14 days in the dose range of 0.5–25 mg

PK parameters were estimated with a noncompartment method. Day 1 PK parameters were not calculated for subjects in 0.5-mg dose panel owing to insufficient numbers of plasma samples above the bioanalytical LLOQ.

Treatment GroupStudy DayCmax (ng/ml) Mean [n] (CV)Tmax (h) Median [n] (Min-Max)AUC(TAU) (ng.h/ml) Mean[n] (CV)Half-Life (h) Mean [n] (S.D.)CLT/F (ml/min) Mean[n] (CV)
0.5 mg1NANANANANA
146.81 [6] (38)3.01 [6] (1.5–4.0)119 [6] (45)NA70.2 [2] (21)
2 mg11.21 [6] (67)14.9 [6] (3.0–23.9)260 [5] (52)NANA
1434.2 [5] (32)2.00 [5] (1.5–2.5)555 [5] (40)67.0 [5] (12.1)60.0 [5] (35)
5 mg118.7 [6] (19)1.75 [6] (1.0–4.0)252 [6] (17)NANA
14114 [6] (55)2.25 [6] (1.5–4.0)1847 [6] (72)65.1 [6] (45.1)45.1 [6] (17)
12 mg181.4 [6] (8)1.75 [6] (1.0–2.5)967 [6] (11)NANA
14276 [6] (40)1.50 [6] (1.0–2.5)4608 [6] (52)68.2 [6] (37.1)43.4 [6] (43)
25 mg1184 [6] (24)1.00 [6] (1.0–3.0)1999 [6] (22)NANA
14405 [6] (28)1.50 [6] (0.5–2.0)5854 [6] (38)34.7 [6] (9.11)71.2 [6] (21)
  • CV, percent coefficient of variation; n, number of subjects with evaluable PK data; NA, not applicable.