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Preclinical studies on the pharmacokinetics, safety, and toxicology of oxfendazole: toward first in human studies

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dc.contributor.author Codd, Ellen E.
dc.contributor.author Ng, Hanna H.
dc.contributor.author McFarlane, Claire
dc.contributor.author Riccio, Edward S.
dc.contributor.author Doppalapudi, Rupa
dc.contributor.author Mirsalis, Jon C.
dc.contributor.author Horton, R. John
dc.contributor.author Gonzalez, Armando E.
dc.contributor.author Garcia, H. Hugo
dc.contributor.author Gilman, Robert H.
dc.date.accessioned 2019-02-06T14:52:38Z
dc.date.available 2019-02-06T14:52:38Z
dc.date.issued 2015
dc.identifier.uri https://hdl.handle.net/20.500.12866/5336
dc.description.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. en_US
dc.language.iso eng
dc.publisher SAGE Publications
dc.relation.ispartof urn:issn:1092-874X
dc.rights info:eu-repo/semantics/restrictedAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
dc.subject Female en_US
dc.subject Male en_US
dc.subject Animals en_US
dc.subject cysticercosis en_US
dc.subject Dogs en_US
dc.subject Mice en_US
dc.subject Dose-Response Relationship, Drug en_US
dc.subject Rats en_US
dc.subject Administration, Oral en_US
dc.subject soil-transmitted helminths en_US
dc.subject Rats, Sprague-Dawley en_US
dc.subject anthelmintic en_US
dc.subject Anthelmintics/adverse effects/pharmacokinetics/toxicity en_US
dc.subject benzimidazole en_US
dc.subject Benzimidazoles/adverse effects/pharmacokinetics/toxicity en_US
dc.subject Cardiovascular System/drug effects en_US
dc.subject Leukemia L5178/genetics en_US
dc.subject Micronucleus Tests en_US
dc.subject Mutagenicity Tests en_US
dc.title Preclinical studies on the pharmacokinetics, safety, and toxicology of oxfendazole: toward first in human studies en_US
dc.type info:eu-repo/semantics/article
dc.identifier.doi https://doi.org/10.1177/1091581815569582
dc.subject.ocde https://purl.org/pe-repo/ocde/ford#3.02.00 es_PE

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