Table 3.

AMG 102 pharmacokinetic parameters

AMG 102 dose cohort (mg/kg)
0.5 (n = 1-7)1 (n = 2-7)3 (n = 1-4)5 (n = 1-4)10 (n = 2-5)20 (n = 3-13)*
Dose141414141414
tmax (h)
    n7273424152133
    Median1.11.51.182.581.0228.11.5111.5822
    Range1-8.421-21-1701-81-24.58-48.11-21-11-2.850.5-2.650.917-241-2.62
Cmax (μg/mL)
    n7273424152133
    Mean15.418.718.138.295.111877.2192234372443695
    SD3.24NC5.296.4644.8NC14.6NC76.2NC115184
C336h (μg/mL)
    n7162414142123
    Mean3.996.325.5412.624.345.925.165.373.5151140356
    SD1.66NC1.74NC9.88NC5.64NC26.3NC45.7125
t1/2 (d)
    n7NC7NC4NC4NC5NC4NC
    Mean15.2NC14.5NC17.5NC20.0NC22.0NC21.6NC
    SD10.0NC6.8NC3.81NC7.88NC11.3NC15.2NC
AUCτ (h·μg/mL)
    n7162414142123
    Mean2,3203,5202,6906,92011,80017,70012,50042,10036,00055,90075,900147,000
    SD462NC553NC4,160NC2,340NC13,400NC18,90035,700
AUC0-inf (h·μg/mL)
    n5NC5NC3NC4NC4NC4NC
    Mean5,600NC6,630NC26,800NC30,900NC91,300NC168,000NC
    SD2,800NC1,950NC1,190NC10,500NC16,400NC112,000NC
CL (mL/h/kg)
    n5NC5NC3NC4NC4NC4NC
    Mean0.104NC0.162NC0.135NC0.176NC0.112NC0.158NC
    SD0.0378NC0.0497NC0.783NC0.0566NC0.0197NC0.0858NC
AR
    nNC1NC2NC1NC1NC2NC3
    MeanNC1.43NC2.39NC1.30NC3.86NC2.25NC2.45
    SDNCNCNCNCNCNCNCNCNCNCNC0.316

Abbreviations: AUC0-inf, AUC from time 0 to infinity; CL, systemic clearance; C336h, observed plasma concentration at 336 h after dose; NC, not calculated; τ, 336 h with once-every-2-wk regimen.

  • *Cohort (20 mg/kg) includes samples from the dose escalation and dose expansion.