Blood and dialysate sampling for abemaciclib, abemaciclib metabolites and urea
BLOOD
Whole blood for pharmacokinetic abemaciclib mi will be obtained pre-dose, time of last dose pre-surgery (less than 14 hours from time of surgery), and then approximately 1, 2, 4, 6, 8, 10, 24, 48 and 72 hours post catheter insertion. Whole blood for urea analysis will be obtained with PK studies at approximately 2, 6, 10, 14, 18, 22, 26, 30, 34, 38, 40, 44, and 48 hours post catheter insertion. At each sample time point a discard blood volume appropriate for the IV access device must be drawn prior to the sample. Blood (3 mL) will be drawn from a peripheral vein in the participant’s arm and collected in green top tubes containing sodium heparin anticoagulant. Tubes will be promptly mixed by gently inverting 6-times, then placed on ice, until centrifuged at 1,300 x g for 10 min at 4°C. Samples will be centrifuged for harvesting plasma within 2 hours. Upon centrifugation, the plasma will be separated from the blood cells using a pipette and transferred into an appropriately labeled polypropylene freezer vial. The samples should be processed to plasma within 30 minutes from centrifugation. Plasma will then be stored frozen at -80°C until subsequent batch analysis. Urea concentration will be evaluated on both blood and dialysate collections (1–2μL/sample minimum).