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. 2013 Apr 12;98(6):2595–2603. doi: 10.1210/jc.2013-1437

Table 3.

PD Response Summary of IGF-I to a Single Dose Administration of VRS-317 in the PK/PD Population (n = 48)

Dose No. Stability, ng/mL Baseline, ng/mL Cmax, ng/mL Cmax (SDS) Tmax, d AUC0–t, ng·h/mL Average, ng/mL
Placebo 9 188 ± 49 106 ± 47 ND ND ND ND 102 ± 49
0.05 mg/kg 8 212 ± 41 97 ± 47 137 ± 58 −1.1 ± 0.7 6.4 ± 6.5 2837 ± 1330 95 ± 44
0.10 mg/kg 8 170 ± 30 57 ± 18 105 ± 43 −1.2 ± 0.9 5.0 ± 2.9 2214 ± 855 74 ± 29
0.20 mg/kg 8 214 ± 68 86 ± 30 196 ± 58 −0.5 ± 0.9 4.1 ± 1.8 3541 ± 1260 118 ± 42
0.40 mg/kg 8 165 ± 44 70 ± 40 248 ± 87 0.9 ± 1.4 4.5 ± 1.4 3771 ± 1524 126 ± 51
0.80 mg/kg 7 197 ± 76 89 ± 31 280 ± 103 1.4 ± 1.3 5.1 ± 2.0 4884 ± 915 163 ± 31

Stability refers to the time during which daily rhGH treatment was given. Baseline refers to day 1, before the dose of VRS-317 or placebo. The IGF-I AUC was calculated using the linear trapezoid rule. Average IGF-I was calculated by dividing AUC by the observation interval of 29 days. The dose proportionality correlation coefficients (log:log) were 0.76 for baseline corrected Cmax and 0.76 for baseline corrected AUC0–t.

Abbreviations: AUC0–t, area under the curve from time zero to the last measurable time point; Cmax, maximum concentration; ND, not determined; Tmax, time to maximum concentration.