Prasugrel nonclinical toxicology
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
nOnclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis - No compound-related tumors were observed in a 2-year rat study with prasugrel at oral doses up to 100 mg/kg/day (>100 times the recommended therapeutic exposures in humans (based on plasma exposures to the major circulating human metabolite). There was an increased incidence of tumors (hepatocellular adenomas) in mice exposed for 2 years to high doses (>250 times the human metabolite exposure).
Mutagenesis - Prasugrel was not genotoxic in two in vitro tests (Ames bacterial gene mutation test, clastogenicity assay in Chinese hamster fibroblasts) and in one in vivotest (micronucleus test by intraperitoneal route in mice).
Impairment of Fertility - Prasugrel had no effect on fertility of male and female rats at oral doses up to 300 mg/kg/day (80 times the human major metabolite exposure at daily dose of 10-mg prasugrel).
References
- ↑ "http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5fe9c118-c44b-48d7-a142-9668ae3df0c6". Retrieved 6 February 2014. External link in
|title=
(help)