A Study of the Absorption, Metabolism, and Excretion of [14C]-AMG 510 Following a Single Oral Dose in Healthy Male Subjects
Study Details
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.
Protocol Summary
Area under the concentration-time curve (AUC) from time zero to infinity (AUCinf)
Timeframe: Day 1 to Day 14
AUC from time zero to the last quantifiable concentration (AUClast)
Timeframe: Day 1 to Day 14
Maximum observed concentration (Cmax)
Timeframe: Day 1 to Day 14
Time of Cmax (tmax)
Timeframe: Day 1 to Day 14
Apparent terminal elimination half-life (t1/2)
Timeframe: Day 1 to Day 14
Total clearance (AMG 510 only; CL/F)
Timeframe: Day 1 to Day 14
Volume of distribution (AMG 510 only; Vz/F)
Timeframe: Day 1 to Day 14
Plasma AMG 510 to total radioactivity ratio
Timeframe: Day 1 to Day 14
Whole blood to plasma total radioactivity ratio
Timeframe: Day 1 to Day 14
Amount (Aeu) of AMG510 excreted in urine
Timeframe: Day 1 to Day 14
Percentage (feu) of AMG510 excreted in urine
Timeframe: Day 1 to Day 14
Renal clearance (CLR) of AMG510
Timeframe: Day 1 to Day 14
Amount (Aef) of AMG510 excreted in feces
Timeframe: Day 1 to Day 14
Percentage (fef) of AMG510 excreted in feces
Timeframe: Day 1 to Day 14
Metabolite profile of AMG 510
Timeframe: Day 1 to Day 14
Identification of AMG 510 metabolites
Timeframe: Day 1 to Day 14
Incidence of adverse events
Timeframe: Up to approximately 6 weeks
QTc interval measured by 12-lead electrocardiogram (ECG)
Timeframe: Up to approximately 6 weeks