Vivjoa: which tox species, and why?

“In rats and dogs, oteseconazole exposure was less dose proportional and the drug accumulated up to 126-fold in dogs with repeated dosing over 39 weeks.”

“Dogs were dosed with oteseconazole for 39 weeks at 0.75, 1.5, 5.5 and 17 mg/kg, equivalent to between 1 and 26 times the MRHD based on AUC comparisons”

“In rats and dogs, oteseconazole exposure was less dose proportional and the drug accumulated up to 126-fold in dogs with repeated dosing over 39 weeks.”

“Reproductive and developmental toxicology studies included fertility studies in male and female rats, embryo-fetal development studies in rats and rabbits, and four pre- and postnatal development studies in rats.”

“There was no increase in the incidence of tumors following daily oral administration of oteseconazole to Tg.rasH2 mice for 6 months at doses of 5 mg/kg/day (males) and 15 mg/kg/day (females), which are up to 3 and 10 times, respectively, the maximum human exposure for RVVC based on AUC comparisons. In an oral carcinogenicity study, Sprague Dawley rats were administered doses of 0.5, 1.5, or 5 mg/kg/day oteseconazole once daily for up to 90 weeks.”

“Dogs were dosed with oteseconazole for 39 weeks at 0.75, 1.5, 5.5 and 17 mg/kg, equivalent to between 1 and 26 times the MRHD based on AUC comparisons”