G. Teuns 1 , B. Verstynen 1 , A. Lampo 1 , W. Coussement 2 . Dept. of Toxicology and Pathology, 1 Drug Evaluation and 2 Full Development, Johnson & Johnson Pharmaceutical R & D, a Division of Janssen Pharmaceutica, Beerse, Belgium In a single dose safety pharmacology study performed according to the Modified Irwin's Test, chlorpromazine hydrochloride was administered orally via gavage to male SPF Wistar rats Hannover substrain ; at single doses of 5, 20 or mg base eq. kg body weight in order to evaluate the neurofunctional integrity in this animal species. Mortality, behavioural observations in the cage and during manipulation, general clinical observations, body weight and weight gain were evaluated during a 7-day observation period following oral administration. Mortality was absent at all doses tested. Neurofunctional integrity of rats was not affected after a single oral dose of chlorpromazine hydrochloride at 5 mg b.e. kg body weight and there were no adverse general observations noted. body weight and weight gain increased at a normal rate during the 7-day observation period. Dosing at 20 mg b.e. kg b.w. led to behavioural motor-affective and sensoro-motor responses ; , neurologic muscle tone, equilibrium and gait ; and autonomic eyes, hypothermia, respiratory rate ; effects, which were considered drug-related. Peak effects were noted after 2 to 4 hours. There were no signs of delayed neurotoxic effects recorded on day 7 post-dosing. General clinical observations were absent during the 1-week observation period. A decrease in weight gain was recorded after 1 week. Dosing at 80 mg b.e. kg b.w. led to behavioural motor-affective and sensoro-motor responses ; , neurologic muscle tone, equilibrium and gait ; and autonomic eyes, secretion and excretion, hypothermia, respiratory rate ; effects. Peak effects were noted after 2 to 4 hours. The duration of action lasted up to 24 hours after dosing. There were no signs of delayed neurotoxic effects recorded on day 7. Dosing at 80 mg b.e. kg b.w. led to a bad condition with a wet urogenital region, a crusty nose and chromodacryorrhea, to agitation and to a decrease in body weight and weight gain, for example, strep throat.
This study was supported by a grant from the Health Research Council of New Zealand. R.W.T. is the recipient of a National Heart Foundation of New Zealand Fellowship. M.R. is the National Heart Foundation of New Zealand Professor of Cardiovascular Studies. Roche Diagnostics donated immunoassay reagents. Barbara Griffin provided technical assistance.
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AE adverse event; LOE lack of efficacy * Other includes protocol deviation including non-compliance ; , lost to follow-up, and non-study related personal reasons. Source: Table 13.3.3, Section 11; Listing 13.3.1b, Appendix B Continued and clomid.
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