Preclinical toxicity and pharmacokinetics of a new orally bioavailable flubendazole formulation and the impact for clinical trials and risk/benefit to patients

新型口服生物可利用氟苯达唑制剂的临床前毒性和药代动力学以及对临床试验和患者风险/益处的影响

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作者:Sophie Lachau-Durand, Lieve Lammens, Bas-Jan van der Leede, Jacky Van Gompel, Graham Bailey, Marc Engelen, Ann Lampo

Background

Flubendazole, originally developed to treat infections with intestinal nematodes, has been shown to be efficacious in animal models of filarial infections. For treatment of filarial nematodes, systemic exposure is needed. For this

Conclusions

Based on these results, in combination with previously described genotoxicity and reproductive toxicity data and the outcome of the preclinical efficacy studies, it was concluded that no flubendazole treatment regimen can be selected that would provide efficacy in humans at safe exposure.

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