Blood and urine collection for PK assessments
BLOOD
Blood samples (4 mL) were collected in K3 EDTA tubes by venipuncture or cannulation. In Part A, samples were taken pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 h post-dose. In part B, samples were taken pre-dose on days 1 (pre-AM dose) and 10 (pre-final dose) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 h post-AM dose for day 1 and post-final dose for day 10. Samples were also taken on days 4–9 pre-AM dose, on day 11 at 24 and 36 h post-final dose, and on day 12 at 48 h post-final dose. Blood samples were centrifuged at 1500 g for 10 min at − 20 °C and split into two plasma aliquots.Urine was collected by spot collection in Part A only before dosing and between 0–6, 6–12, 12–24, and 24–48 h post-dose. Blood and urine aliquots were stored in polypropylene tubes at − 70 °C until bioanalysis. Plasma and urine concentrations of GB1211 were measured using validated liquid chromatography methods with tandem mass spectrometry detection with lower limits of quantification of 0.500 ng/mL in both biological media.