Abstract
10 male Sprague Dawley rats per group received a single dose of either sterile physiological saline with 0.1% human serum albumin or NT 201 in doses 8, 16 or 32 LDU/kg by i.m. injection. An i.m. injection of 20 mg/kg morphine served as positive control. At 4 days after administration of NT 201 or vehicle paralysis was assessed, before the rats received a charcoal meal of 2.5 mL of 10% charcoal suspension in 5% arabic gum in sterile water. Morphine-treated rats got the charcoal meal 45 min after the injection. The NT 201 dose range and timing of the charcoal meal administration was based on a dose-range-finding study conducted prior to this study. At 20 min after administration of the charcoal meal, animals were sacrificed and the distance travelled by the charcoal in the GI tract was assessed. Intestinal transit was expressed as percentage of the total intestinal tract length. Paralysis of the injected hind limb was confirmed in all rats treated with NT 201 4 days after i.m. injection right before the charcoal meal. NT 201 administered i.m. at doses of 8, 16 and 32 mg/kg did not statistically significantly affect the intestinal transit. The positive control morphine induced a significant inhibition of charcoal meal propulsion. In this study the NOAEL of single i.m. injection of NT 201 for effects on gastro-intestinal motility in rats is at least 6 times higher than the max. recommended clinical dose.
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