The primary objectives of the study are: to characterize the primary route(s) of elimination of \[14C\]-AMG 510 and drug-related material, and estimate the overall recovery of radiolabeled material in healthy male participants after oral administration of \[14C\]-AMG 510, and to characterize the pharmacokinetic (PK) of total radioactivity and AMG 510 following a single oral dose of \[14C\]-AMG 510 in healthy male participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
Single oral dose of AMG510.
Covance Clinical Research Unit, Inc
Madison, Wisconsin, United States
Area under the concentration-time curve (AUC) from time zero to infinity (AUCinf)
Time frame: Day 1 to Day 14
AUC from time zero to the last quantifiable concentration (AUClast)
Time frame: Day 1 to Day 14
Maximum observed concentration (Cmax)
Time frame: Day 1 to Day 14
Time of Cmax (tmax)
Time frame: Day 1 to Day 14
Apparent terminal elimination half-life (t1/2)
Time frame: Day 1 to Day 14
Total clearance (AMG 510 only; CL/F)
Time frame: Day 1 to Day 14
Volume of distribution (AMG 510 only; Vz/F)
Time frame: Day 1 to Day 14
Plasma AMG 510 to total radioactivity ratio
Time frame: Day 1 to Day 14
Whole blood to plasma total radioactivity ratio
Time frame: Day 1 to Day 14
Amount (Aeu) of AMG510 excreted in urine
Time frame: Day 1 to Day 14
Percentage (feu) of AMG510 excreted in urine
Time frame: Day 1 to Day 14
Renal clearance (CLR) of AMG510
Time frame: Day 1 to Day 14
Amount (Aef) of AMG510 excreted in feces
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1 to Day 14
Percentage (fef) of AMG510 excreted in feces
Time frame: Day 1 to Day 14
Metabolite profile of AMG 510
Time frame: Day 1 to Day 14
Identification of AMG 510 metabolites
Time frame: Day 1 to Day 14
Incidence of adverse events
Adverse events will be graded by severity. Laboratory abnormalities (hematology, clinical chemistry, and urinalysis test results) will be recorded as adverse events, in addition to abnormalities in vital signs and physical examinations.
Time frame: Up to approximately 6 weeks
QTc interval measured by 12-lead electrocardiogram (ECG)
Time frame: Up to approximately 6 weeks