This study will investigate the metabolic fate and routes of excretion of 14CAZD0914 in six male healthy volunteers.
This is an open-label, single dose study in 6 healthy male subjects aged 18 to 55 years. Each subject will be admitted to the clinical pharmacology unit on the day prior to dosing Check in (Day -1) and will remain in the clinical pharmacology unit until up to at least target Day 8 (168 hours post-dose). All subjects will receive 3000 mg AZD0914 incorporating 18.5 MBq (500 Ci) of \[14C\] administered as a single oral dose following at least an 8 hour fast from food. Subjects can have water. For specific food and water restrictions. This study will investigate the metabolic fate and routes of excretion of AZD0914.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
Radiolabelled AZD0914 for study of absorption, disposition, metabolism, and excretion in healthy volunteers.
Covance Clinical Research Unit
Madison, Wisconsin, United States
Research Site
Madison, Wisconsin, United States
PK Parameters
Maximum observed concentration (Cmax), time to maximum observed concentration (tmax), area under the concentration-time curve from hour 0 to the last measurable concentration (AUC0-t), area under the concentration-time curve extrapolated to infinity (AUC0-inf), apparent terminal elimination rate constant (lambdaZ), apparent terminal elimination half-life (t1/2), apparent clearance (Cl/F) (oral and AZD0914 only), and apparent volume of distribution (Vz/F) (AZD0914 only). Ratios for area under the concentration-time curve extrapolated to infinity including the ratio of total radioactivity in whole blood/plasma and the ratio of non-radiolabeled AZD0914 in plasma/total radioactivity in plasma, will be calculated as appropriate.
Time frame: Up to 11 days
Urine and Feces PK Parameters
The following pharmacokinetic parameters will be calculated, whenever possible, based on the urine total radioactivity concentrations: amount excreted in urine (Aeu) over the sampling interval, renal clearance (CLR), and the percent excreted in urine (%Feu). For fecal total radioactivity concentrations, the following pharmacokinetic parameters will be calculated for \[14C\] AZD0914 derived radioactivity: amount excreted in feces (Aef) over the sampling interval and the percent excreted in feces (%Fef).
Time frame: Up to 11 days
Metabolites
Metabolites of \[14C\]-AZD0914 will be identified. Pharmacokinetic parameters for the metabolites of \[14C\]-AZD0914 will be calculated, as deemed appropriate, based on plasma and urine concentration levels. Data may be presented in a separate report.
Time frame: Up to 11 days
Number and severity of adverse events, abnormal labs, signs, ECGs, and PEs
Signs, symptoms, incidence, and severity of adverse events (AE), abnormalities in clinical laboratory assessments, vital signs, electrocardiograms (ECGs), and physical examinations.
Time frame: Up to 17 days
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