Triethylenetetramine Dihydrochloride Palatability

摘要

The purpose of the study was to determine concentrations of triethylenetetramine dihydrochloride (CAS No. 38260-01-4) that would be acceptable in the drinking water of Fischer 344 Rats and B6C3F1 mice in subsequent studies with the compound. The results of the study will help in planning subsequent 90 day studies with Trien-2HC1 in Fischer 344 rats and B6C3F1 mice. Trien-2HC1 is a chelating agent purposed for use in the treatment of Wilson's disease patients who are intolerant of d-penicillamine, another chelating agent currently being used for treating the rare disease. Since the incidence of Wilson's disease is small and the number of patients who cannot tolerate d-penicillamine is approximately 10% of those with the disease, Trien-2HC1 has been included in the Orphan Drug Program. Accordingly, the study reported here and subsequent 90 day studies to be done in rats and mice will provide preclinical toxicological data important for the clearance of the drug prior to routine use in the treatment of Wilson's disease.