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Table 5 Summary of LY2603618 noncompartmental pharmacokinetic parameter estimates

From: A phase II study to evaluate LY2603618 in combination with gemcitabine in pancreatic cancer patients

Parameter

Geometric Mean (CV%) 230 mg LY2603618

Cycle 1

Day 2

Day 16

(n = 58)

(n = 48)

Cmax (ng/mL)

3170 (50)

3410 (50)

tmax a (h)

1.00 (0.88–1.38)

1.00 (0.88–1.83)

Cav,24 (ng/mL)

966 (68) d

987 (60) e

AUC(0–24) (ng*h/mL)

23200 (68) d

23700 (60) e

AUC(0-∞) (ng*h/mL)

29400 (84) d

29100 (74) e

AUC(tlast-∞) (%)

14.3 (131) d

12.0 (152) e

CL (L/h)

7.79 (84) d

7.87 (74) e

Vss (L)

104 (48) d

95.1 (42) e

t1/2 (h)

9.67 (48) d

8.86 (48) e

RA b

108 (32) f

RA c

  1. AUC (0 - ∞) area under the plasma concentration time-curve from time 0 to infinity; AUC (0–24) area under the plasma concentration time-curve from time 0 to 24 h; AUC (tlast - ∞) fraction of AUC(0 - ∞) extrapolated from the time of the last measurable plasma concentration (tlast) to infinity; C av,24 average plasma concentration over 24 h calculated using AUC(0–24); CL systemic clearance; C max maximum plasma concentration; CV% percent coefficient of variation; m 2 meters squared; mg milligrams; n number of pharmacokinetic observations; NC not calculated; R A accumulation ratio; t max time of maximum observed plasma concentration; V ss volume of distribution at steady state following intravenous (IV) administration; t 1/2 elimination half-life
  2. aMedian (range)
  3. bIntracycle accumulation ratio [Cycle 1 Day 16 AUC(0 - ∞)/Cycle 1 Day 2 AUC(0 - ∞)]
  4. cIntercycle accumulation ratio [Cycle 2 Day 2 AUC(0 - ∞)/Cycle 1 Day 2 AUC(0 - ∞)]
  5. d n = 54
  6. e n = 42
  7. f n = 38