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. 2017 Aug 16;18(3):1470320317717883. doi: 10.1177/1470320317717883

Table 1.

Summary statistics of LY3045697 plasma pharmacokinetic (PK) parameters after single and multiple-daily dosing in the fed state by dose group (geometric mean (coefficient of variation (CV)%)).

Variable 0.1 mg
LY3045697
(n=6)
0.3 mg
LY3045697
(n=6)
1 mg
LY3045697
(n=6)
3 mg
LY3045697
(n=6)
10 mg
LY3045697
(n=6)
30 mg
LY3045697
(n=6)
100 mg
LY3045697
(n=6)
300 mg
LY3045697
(n=6)
After single daily dose of LY3045697 in the fed state
Cmax (ng/ml) 0.32 (28) 1.10 (33) 1.96 (49) 9.95 (37) 27.9 (24) 83.7 (25) 458 (27) 951 (20)
tmax (h)a 0.75 (0.50–1.00) 0.50 (0.50–1.00) 1.00 (0.50–2.00) 0.50 (0.50–0.50) 0.75 (0.50–2.00) 1.00 (0.50–2.00) 0.50 (0.50–1.00) 0.50 (0.50–1.00)
AUC0–inf (h*ng/ml) nrb nrb 12.1 (51)c 49.1 (31)d 138 (19) 482 (32) 1726 (15) 6226 (19)
t1/2 (h) nrb nrb 9.11 (43)c 8.73 (32)d 9.99 (20) 9.57 (20) 9.62 (28) 10.8 (30)
After 8 once-daily doses of LY3045697 in the fed state
(n=12) (n=12) (n=12) (n=12)
Cmax (ng/ml) 0.368 (30) 3.45 (36) 37.4 (29) 371 (37)
tmax (h) a 0.95 (0.50–3.00) 0.95 (0.50–3.00) 0.95 (0.50–2.00) 0.95 (0.50–0.95)
AUC0–tau (h*ng/ml) NC 19.2 (29) 195 (22) 1818 (28)
t1/2 (h) e e 9.84 (18) 10.8 (26)

AUC0–inf : area under the plasma concentration-time curve from time 0 to infinity; AUC0–tau: area under the plasma concentration-time curve during the dosing interval of 24 h; Cmax: maximum observed plasma concentration; CI: confidence interval; h: hour; n: number of subjects exposed; NC: if no quantifiable observations were reported until 24 h post-dose than AUC0–tau was not calculated; nr: not reported; t1/2: terminal elimination half-life; tmax: time to attain Cmax.

a

Median (range); bhalf-life and other PK parameters that rely on the terminal phase elimination rate constant were not calculable due to inadequate quantifiable observation interval; cn=3; dn=5; enot reported due to inadequate quantifiable terminal phase.