Jesduvroq: which tox species, and why?

“General toxicology studies of 4- and 13-weeks duration were conducted in Sprague Dawley rats and Beagle Dogs with rats receiving daily oral doses by gavage and dogs by capsule. A 13-week toxicity study was also conducted in the cynomolgus monkey with daily dosing by oral gavage.”

“The 3 major circulating human metabolites (M2, M3, and M13) were present in rabbit and monkey plasma with an animal:human AUC ratio of at least 1X in monkeys (comparing the 50 mg/kg MTD dose in the 39-week toxicity study and human exposure at the 48 mg three times a week (TIW) human dose).”

“Title/ Study No.: GSK1278863A: A 26-week Oral (Gavage) Toxicity Study in the Rat/ 2011N126130”