This is a phase I, open label, healthy volunteers, ADME study with single oral administration of \[14C\]-AZD4205.
Phase I study to evaluate the excretion of AZD4205 radioactive dose, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of \[14C\]-AZD4205 in healthy male volunteers. The purpose of this study is to investigate ADME properties of AZD4205 by analyzing blood, urine and feces collected during the study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
8
Each subject will receive 50 mg AZD4205 oral solution (free base equivalent) containing a nominal dose of 15 µCi \[14C\]- radiolabelled AZD4205 as a single administration .
Pharmaron CPC
Baltimore, Maryland, United States
Percentage of radioactive dose recovered in urine and faeces and total percentage
To evaluate the percentage of radioactive dose of \[14C\] radiolabelled AZD4205 recovered in urine, feces, and in total
Time frame: Up to 57 days
Provide samples for subsequent studies
Provide samples for subsequent studies to characterize the metabolism of \[14C\]AZD4205
Time frame: Up to 57 days
AUC(0-inf) for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting AUC(0-inf)
Time frame: Up to 57 days
AUC(0-t) for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting AUC(0-t)
Time frame: Up to 57 days
Cmax for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting Cmax
Time frame: Up to 57 days
tmax for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting tmax
Time frame: Up to 57 days
tlag for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting tlag
Time frame: Up to 57 days
t1/2 for [14C] radioactivity in plasma and whole blood
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To determine AZD4205 plasma concentrations and the resulting t1/2
Time frame: Up to 57 days
λz for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting λz
Time frame: Up to 57 days
CL/F for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting CL/F
Time frame: Up to 57 days
Vss/F for [14C] radioactivity in plasma and whole blood
To determine AZD4205 plasma concentrations and the resulting Vss/F
Time frame: Up to 57 days
Distribution of total radioactivity in blood
To compare disposition of drug-related total radioactivity in whole blood to that in plasma
Time frame: Up to 57 days