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Thirteen-week oral toxicity study of the new cognition-enhancing agent nefiracetam in rats
1Drug Safety Research Center, Developmental Research Laboratories, Daiichi Pharmaceutical Co., Ltd., Tokyo, Japan.
Abstract:
Thirteen-week toxicity of nefiracetam (N-(2,6-dimethylphenyl)-2-(2-oxo-1- pyrrolidinyl) acetamide, DM-9384, CAS 77191-36-7) was examined in rats by oral administration of 30, 120, or 480 mg/kg. Rats receiving 480 mg/kg showed salivation, prone position, increased water consumption, increased levels of serum total cholesterol, total protein, albumin and total bilirubin, increased liver weight and hypertrophy of liver cells. This hypertrophy of hepatocytes with increased liver weight was also observed in males at 120 mg/kg. The non-toxic dose of nefiracetam under the present experimental conditions was therefore determined as 30 mg/kg.