Table 3 Pharmacokinetic parameters of vorolanib after single administration and multiple dosing.

From: Safety and tolerability of oral vorolanib for neovascular (wet) age-related macular degeneration: a phase I, open-label study

 

25 mg

50 mg

75 mg

Single dose

n = 8

n = 8

n = 8

 AUC0-24h, h*ng/mL

1007.4 (41.4)

1726.4 (35.1)

1704.3 (27.4)

 Cmax, ng/mL

140.4 (38.8)

201.4 (37.1)

236.7 (21.7)

 Tmax, h

3.03 (2.00–8.00)

6.00 (2.02–8.00)

4.00 (3.00–6.00)

 t1/2, h

5.9 (33.3)

10.7 (90.5)

10.3 (103.3)

Multiple doses

n = 0

n = 8

n = 8

 AUCss, h*ng/mL

–

2178.8 (38.9)

1949.6 (34.0)

 Cmax,ss, ng/mL

–

245.7 (34.6)

268.7 (35.5)

 Tmax,ss, h

–

5.03 (4.00–8.00)

4.00 (2.93–6.00)

 Rac

–

1.30 (31.3)

1.20 (36.2)

 CLss/F, L/h

–

26.2 (40.1)

42.4 (32.7)

 t1/2, h

–

4.9 (19.1)

7.3 (38.6)

 Vz/F, L

–

179.8 (34.9)

436.1 (47.6)

  1. Data represent the arithmetic mean (percentage coefficient of variation) except for Tmax and Tmax,ss, which are the median (range).
  2. AUC area under the plasma concentration–time curve. Cmax maximum plasma concentration. Tmax time to reach Cmax, Tmaxx,ss time to reach Cmax at steady state. t1/2 apparent terminal elimination half-life. Rac accumulation ratio based on AUCss, CLss/F apparent oral clearance, Vz/F apparent volume of distribution.
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