2015 ACVIM Forum Research Abstract Program

SAFETY OF THE GHRELIN AGONIST, CAPROMORELIN, ADMINISTERED DAILY TO CATS FOR 91 DAYS AT AN ORAL DOSE OF 6 MG/KG. Bill Zollers, Julie Allen, Chelsey Kennedy, Linda Rhodes. Aratana Therapeutics, Inc., Kansas City, KS, USA Capromorelin, a ghrelin agonist, is under development for use in cats. This controlled, non-GLP, study evaluated the safety of capromorelin in laboratory cats. Two treatment groups were included, following an 11-day acclimation phase, with 4 adult cats receiving an oral placebo solution (Group 1) and 8 adult cats receiving an oral capromorelin solution at 6 mg/kg (Group 2) for 91 consecutive days. All cats were weighed on Days À11, À1, 1, 14, 30, 59, 75 and 91. Physical examinations were performed on Days À11, 1, 30, 59 and 91 and animals were observed at least once daily throughout the study period. On Days 1 through 91, animals were administered a flavored oral solution of placebo or capromorelin once daily via syringe. Hematology, serum chemistry (including fructosamine) and urinalyses were conducted on Days -5 (acclimation) and Days 30, 59 and 91, approximately 1 hour following dose administration. On Days 1, 30, 59 and 91, blood samples were collected prior to daily dose administration and 8 hours post-dose and serum IGF-1 and GH levels measured. Beginning 1 hour post-dose, all cats were offered food during a 6-hour period. Variables of interest included weight gain/loss, food consumption, clinical pathology (hematology, chemistry, and urinalysis), and serum analysis of IGF-1 and GH.