TABLE 2

Mass balance of unchanged 14C-apalutamide and its metabolites expressed as a percentage of the administered dose and found in urine and feces after oral administration of 240 mg of apalutamide

ComponentUrineFeces
0–240 h240–1680 h0–1680 h0–240 h240–1680 h0–1680 h
% Inj% Dose% Inj% Dose% Dose% Inj% Dose% Inj% Dose% Dose
M20.60.170.20.070.23
M33.50.984.81.752.737.90.628.31.351.97
M444.612.5351.518.5931.128.80.6910.41.692.38
M82.20.610.80.290.902.50.201.20.190.39
M91.00.290.60.210.5020.51.6111.61.883.49
M10TraceTraceTraceTraceTrace
M112.40.661.20.451.11
M12 + M13 + M148.42.356.62.384.7311.1a0.87a23.4a3.79a4.67a
M153.00.842.00.711.54TraceTraceTraceTraceTrace
M17TraceTraceTraceTraceTraceTraceTraceTraceTraceTrace
M180.50.140.40.130.274.20.333.50.570.90
M1911.73.295.62.025.312.50.201.30.210.41
M207.72.1713.04.686.851.40.111.10.170.29
M21 + M223.20.914.21.532.44
Unchanged drug3.30.920.80.281.2011.50.913.90.641.54
Sum of reported entities92.025.991.233.058.870.55.564.810.516.0
Sum of observed metabolites (dose %)28.136.164.27.916.224.1
  • % Dose, percentage of oral dose; % Inj, percentage of 14C injected onto the HPLC column.

  • a Includes M13 + M14 only.