ArticleJournal of pharmacokinetics and pharmacodynamics2023
Pharmacometric model of agalsidase-migalastat interaction in human: a novel mechanistic model of drug-drug interaction between a therapeutic protein and a small molecule.
Article in Journal of pharmacokinetics and pharmacodynamics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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3 authors at 2 institutions in 1 country.
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Abstract
Recently, a new mechanism of drug-drug interaction (DDI) was reported between agalsidase, a therapeutic protein, and migalastat, a small molecule, both of which are treatment options of Fabry disease. Migalastat is a pharmacological chaperone that stabilizes the native form of both endogenous and exogenous agalsidase. In Fabry patients co-administrated with agalsidase and migalastat, the increase in active agalsidase exposure is considered a pharmacokinetic effect of agalsidase infusion but a pharmacodynamic effect of migalastat administration, which makes this new DDI mechanism even more interesting. To quantitatively characterize the interaction between agalsidase and migalastat in human, a pharmacometric DDI model was developed using literature reported concentration-time data. The final model includes three components: a 1-compartment linear model component for migalastat; a 2-compartment linear model component for agalsidase; and a DDI component where the agalsidase-migalastat complex is formed via second order association constant k
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