NCD1540 4 Weeks 200 ♂=117; ♂≈8 ♀≈8 ♂≈2; ♀≈2 ♀=112 Rat (Wistar) IV 600 ♂=352ˢ; ♂≈25; ♂≈6; ♀≈6 infusion ♀=323 ♀≈23 1000 ♂=658; ♂≈47; ♂≈11; ♀≈9 ♀=517 ♀≈37 PSM1029 26 Weeks 150 ♂=75.4; ♂≈5; ♀≈6 ♂≈1; ♀≈1 ♀=82.6 Rat PO (Wistar) 230 ♂=151; ♂≈11; ♂≈3; ♀≈3 ♀=151 ♀≈11 450 ♂=276ˢ; ♂≈20; ♂≈5; ♀≈5 ♀=276 ♀≈20 NCD1305 52 Weeks 150 ♂=102; ♂≈7; ♀≈7 ♂≈2; ♀≈2 ♀=92.7 Rat PO (Wistar) (104 230 ♂=167; ♂≈12; ♂≈3; ♀≈3 week ♀=154 ♀≈11 450 ♂=337; ♂≈24; ♂≈6; ♀≈6 ♀=347 ♀≈25 700 ♂=476ˢ; ♂≈34; ♂≈8; ♀≈8 ♀=449 ♀≈32 PSM1013 26 Weeks 15 28.5 ≈2 ≈0.5 Dog PO 37.5 59.9 ≈4 ≈1.0 (Beagle) 75 106 ≈8 ≈2 NCD1543 4 30 70.9 ≈5 ≈1 Dog 100 161 ≈11 ≈3 (Beagle) IV infusion 150/200 305 ≈22 ≈5 PSM1101 4 Weeks 300 649 ≈46 ≈11 Monkey PO 600 1069 ≈76 ≈19 900 1231 ≈87 ≈21 PSM1140 39 Weeks 300 ≈729 ≈52 ≈13 Monkey PO 600 ≈1054 ≈75 ≈18 900 ≈1458 ≈103 ≈25 * at termination unless otherwise noted. # Healthy volunteer data from Study No. N01109 for 200 mg PO dose AUC= 14.1 severe renal impairment data - AUC= 57.5 – μg.h/mL, μg.h/mL
NCD1540 Rat (Wistar) 4 Weeks IV infusion 200 ♂=117; ♀=112 ♂≈8 ♀≈8 ♂≈2; ♀≈2 600 ♂=352ˢ; ♀=323 ♂≈25; ♀≈23 ♂≈6; ♀≈6 1000 ♂=658; ♀=517 ♂≈47; ♀≈37 ♂≈11; ♀≈9 PSM1029 Rat (Wistar) 26 Weeks PO 150 ♂=75.4; ♀=82.6 ♂≈5; ♀≈6 ♂≈1; ♀≈1 230 ♂=151; ♀=151 ♂≈11; ♀≈11 ♂≈3; ♀≈3 450 ♂=276ˢ; ♀=276 ♂≈20; ♀≈20 ♂≈5; ♀≈5 NCD1305 Rat (Wistar) 52 Weeks PO (104 week 150 ♂=102; ♀=92.7 ♂≈7; ♀≈7 ♂≈2; ♀≈2 230 ♂=167; ♀=154 ♂≈12; ♀≈11 ♂≈3; ♀≈3 450 ♂=337; ♀=347 ♂≈24; ♀≈25 ♂≈6; ♀≈6 700 ♂=476ˢ; ♀=449 ♂≈34; ♀≈32 ♂≈8; ♀≈8 PSM1013 Dog (Beagle) 26 Weeks PO 15 28.5 ≈2 ≈0.5 37.5 59.9 ≈4 ≈1.0 75 106 ≈8 ≈2 NCD1543 Dog (Beagle) 4 IV infusion 30 70.9 ≈5 ≈1 100 161 ≈11 ≈3 150/200 305 ≈22 ≈5 PSM1101 Monkey 4 Weeks PO 300 649 ≈46 ≈11 600 1069 ≈76 ≈19 900 1231 ≈87 ≈21 PSM1140 Monkey 39 Weeks PO 300 ≈729 ≈52 ≈13 600 ≈1054 ≈75 ≈18 900 ≈1458 ≈103 ≈25 * at termination unless otherwise noted. # Healthy volunteer data from Study No. N01109 for 200 mg PO dose – AUC= 14.1 μg.h/mL, severe renal impairment data - AUC= 57.5 μg.h/mL
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