NCD1982 13 week 500 ♂=268; ♂=161; ♂≈8; ♀≈8 ♀=289 Rat (Wistar) continuous IV infusion 1000 ♂=605; ♂≈17; ♀=775 ♀≈22 2000 ♂≈34; ♀≈51 ♀=1818 * at study termination unless otherwise noted. # Healthy volunteer data from Study No. N01109 for 200 mg PO dose AUC= 1.67 severe renal impairment data - AUC= 35.8 – μg.h/mL, μg.h/mL Relative exposure margins for metabolite ucb-102933-1 in adults TK data for this metabolite are available in the animal studies, it is generally not found in humans. It is of important as a biomarker for hepatic porphyria in animals, particularly in dogs. 12: Relative exposure margins for metabolite ucb-107092-1. Study Study Brivaracetam AUC0–24h Exposure duration Dose or ratio# Species Route (mg/kg/day) AUC0–τ PSM1256 13 Weeks 450 Generally not ♂=22.5 found in (CD-1) PO ♀=11.5 humans 675 Generally not ♂=56.5 found in ♀=28.7 humans 1000 Generally not ♂=86.4 found in ♀=69.9 humans PSM1029 26 Weeks 150 Generally not ♂=3.67 found in Rat (Wistar) PO ♀=3.66 humans 230 Generally not ♂=6.87 found in ♀=6.02 humans 450 Generally not ♂=16.3 found in ♀=14.4 humans PSM1013 15 26 Weeks 11.8 Generally not in humans
NCD1982 Rat (Wistar) 13 week continuous IV infusion 500 ♂=268; ♀=289 ♂=161; ♂≈8; ♀≈8 1000 ♂=605; ♀=775 ♂≈17; ♀≈22 2000 ♀=1818 ♂≈34; ♀≈51 * at study termination unless otherwise noted. # Healthy volunteer data from Study No. N01109 for 200 mg PO dose – AUC= 1.67 μg.h/mL, severe renal impairment data - AUC= 35.8 μg.h/mL Relative exposure margins for metabolite ucb-102933-1 in adults TK data for this metabolite are available in the animal studies, it is generally not found in humans. It is of important as a biomarker for hepatic porphyria in animals, particularly in dogs. 12: Relative exposure margins for metabolite ucb-107092-1. Study Species Study duration Route Brivaracetam Dose (mg/kg/day) AUC0–24h or AUC0–τ Exposure ratio# PSM1256 (CD-1) 13 Weeks PO 450 ♂=22.5 ♀=11.5 Generally not found in humans 675 ♂=56.5 ♀=28.7 Generally not found in humans 1000 ♂=86.4 ♀=69.9 Generally not found in humans PSM1029 Rat (Wistar) 26 Weeks PO 150 ♂=3.67 ♀=3.66 Generally not found in humans 230 ♂=6.87 ♀=6.02 Generally not found in humans 450 ♂=16.3 ♀=14.4 Generally not found in humans PSM1013 26 Weeks 15 11.8 Generally not in humans
auspar-brivaracetam-170307.docx