This study is designed to utilize computer modeling of the US population through the ongoing CDC NHANES trial to reduce the need for preclinical formulation and toxicology studies of an Ebola antiviral (BSN389) being repurposed for COVID-19, and to thereby speed the candidate therapeutic to the clinic. BSN389 has poor solubility in water and that limits its bioavailability. BCD greatly increases the solubility of BSN389 and results in high bioavailability of BSN389 in animal studies. The goal of this study is to determine the current daily exposure of the population to beta cyclodextrin (BCD), and then keep the amount of BCD in the formulation below that level, so drug use does not add significantly to BCD exposure of human subjects. Data from the Centers for Disease Control (CDC) National Health and Nutrition Examination Survey (NHANES) are combined in this computational experiment with data on international BCD shipments from ingredient manufacturers to evaluate exposure of the US population.
The project described was supported by NSF ACI-1053575 allocation number BIO170011 and the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant UL1TR001998.
A preprint of this article is available on medRxiv.
Campbell, Heather R.; Cecil, Regan P.; and Lodder, Robert A., "Population Data-Driven Formulation of a COVID-19 Therapeutic" (2020). Pharmaceutical Sciences Faculty Publications. 160.