Skip to main content

Table 4 Single- and multiple-dose PK of AZD9773 total Fabs

From: A placebo-controlled, double-blind, dose-escalation study to assess the safety, tolerability and pharmacokinetics/pharmacodynamics of single and multiple intravenous infusions of AZD9773 in patients with severe sepsis and septic shock

  AZD9773 cohort 1
(50 U/kg)
(n= 7)
AZD9773 cohort 2
(250 U/kg) (n= 8)
AZD9773 cohort 3
(250/50 U/kg) (n= 6)§
AZD9773 cohort 4
(500/100 U/kg) (n= 7)§
AZD9773 cohort 5
(750/250 U/kg)
(n= 4)§
AUC0-12, μg.h/mL* 125.2 ± 79.8 581.0 ± 94.04 449.2 ± 46.8 691.5 ± 22.7 1872 ± 28.4
AUC0-12, μg.h/mL* - - 162.8 ± 82.2 251.6 ± 56.0 981.0 ± 39.3
Cinf, μg/mL* 29.6 ± 112.5 156.2 ± 208.1 - - -
Cinf, μg/mL* - - 28.4 ± 52.9 42.5 ± 83.5 151.8 ± 14.7
Accumulation ratio* - - 1.9 ± 32.0 1.6 ± 79.1 1.6 ± 38.1
tmax, hours** 1.5 (1.4 to 3.5) 2.1 (1.0 to 4.3) 0.5 (0 to 0.7) 1.0 (0.4 to 8.5) 0.7 (0.5 to 1.6)
t1/2, hours 18.0 ± 7.3 19.8 ± 5.2 - - -
CL, mL/min/kg 6.1 ± 3.4 7.6 ± 6.0 - - -
Vss, mL/kg 92.6 ± 30.8 152.8 ± 132.8 - - -
Dose excreted, %* 10.6 ± 69.3 15.0 ± 100.4 15.2 ± 57.1 11.8 ± 94.0 20.9 ± 223.1
  1. Data presented as: *Geometric mean ± coefficient of variation; **Median (range); Mean ± SD; Values for single doses (cohorts 1 and 2) or loading doses (cohorts 3 to 5); §Values based on maintenance doses unless stated otherwise. Note: The multiple dosing profile was not followed for sufficient time to enable the calculation of t1/2, CL and Vss for cohorts 3 to 5. AUC0-12, area under the serum concentration-time curve from 0 to 12 hours; Cinf, maximum (end of infusion) serum concentration; CL, total apparent drug clearance; t1/2, terminal half-life; tmax, time to reach Cinf; Vss, apparent volume of distribution at steady state