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Article  2015

Preclinical Studies on the Pharmacokinetics, Safety, and Toxicology of Oxfendazole: Toward First in Human Studies

SRI Authors Jon C. Mirsalis

Citation

COPY

Codd, E. E., Ng, H. H., McFarlane, C., Riccio, E. S., Doppalapudi, R., Mirsalis, J. C., . . . Cysticercosis Working Group. (2015). Preclinical studies on the pharmacokinetics, safety, and toxicology of oxfendazole: toward first in human studies. International Journal of Toxicology, 34(2), 129-137. doi: 10.1177/1091581815569582

Abstract

A 2-week study in rats identified target organs of oxfendazole toxicity to be bone marrow, epididymis, liver, spleen, testis, and thymus. Female rats had greater oxfendazole exposure and exhibited toxicities at lower doses than did males. Decreased white blood cell levels, a class effect of benzimidazole anthelmintics, returned to normal during the recovery period. The no observed adverse effect level was determined to be >5 but <25 mg/kg/d and the maximum tolerated dose 100 mg/kg/d. The highest dose, 200 mg/kg/d, resulted in significant toxicity and mortality, leading to euthanization of the main study animals in this group after 7 days. Oxfendazole did not exhibit genetic toxicology signals in standard Ames bacterial, mouse lymphoma, or rat micronucleus assays nor did it provoke safety concerns when evaluated for behavioral effects in rats or cardiovascular safety effects in dogs. These results support the transition of oxfendazole to First in Human safety studies preliminary to its evaluation in human helminth diseases

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