The toxicity profile of different excipient combinations was evaluated upon daily administration of enteric coated tablets via oral capsules to female beagle dogs for 27 days. Dogs were assigned across seven groups (3/group) and tablets containing different excipient combinations were administered by oral gavage once daily to determine which excipient(s) is responsible for causing the renal toxicity that had been observed in repeat-dose toxicology studies conducted with MEDI7219 enteric coated tablets (Table ). Results of this investigative 4-week study of orally administered enteric coated excipient tablets in beagles revealed PG as the possible cause of renal toxicity (Table ). With different combinations of excipients including PG administered orally, nephrotoxicity was only observed in dogs dosed with formulations comprising PG. In a follow-up study, 200 mg/kg/day PG alone administered in standard gelatin capsules, which yielded similar PG systemic exposures as the enteric coated tablets, did not result in nephrotoxicity (data not shown).