ArticleEuropean journal of drug metabolism and pharmacokinetics2026
Optimization of Dosing Regimens for Plasminogen Activation Inhibitor BT-114143 Using a Small Molecule TMDD Population PK and PD Model in Healthy Subjects.
Article in European journal of drug metabolism and pharmacokinetics, 2026. 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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Abstract
BACKGROUND AND
objectiveBT-114143 is a novel, small-molecule antifibrinolytic agent that promotes hemostasis by inhibiting the conversion of plasminogen to plasmin. Due to its strong binding to this target, the drug exhibits target-mediated drug disposition (TMDD). This is characterized by nonlinear pharmacokinetics (PK) at low doses that transition to linearity at higher, target-saturating doses. In this study, a population pharmacokinetic-pharmacodynamic (PopPK-PD) model for BT-114143 was developed to guide dose selection for a subsequent multiple ascending dose (MAD) study.
methodUsing PK and PD data from a single ascending dose (SAD) study of intravenously administered BT-114143, a PopPK-PD model was developed.
resultsThe PopPK-PD analysis established that a TMDD PK model, combined with a sigmoid E
conclusionThis study reports the first PopPK-PD model for a novel, plasminogen-targeting small-molecule exhibiting TMDD properties. The model was subsequently used to inform and support the design of multiple-dose regimens for future clinical studies in patients.
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