ArticleAntimicrobial agents and chemotherapy2021
Population Pharmacokinetic Model of Oxfendazole and Metabolites in Healthy Adults following Single Ascending Doses.
Article in Antimicrobial agents and chemotherapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed, 7 citations in OpenAlex.
- Repurposing Oxfendazole for Onchocerciasis: Population Pharmacokinetics of a Tablet Formulation in Healthy African Adults.CPT: pharmacometrics & systems pharmacology · 2026Trial
- A Phase IIa, Proof-of-Concept, Placebo-Controlled, Randomised Trial to Investigate the Efficacy and Safety of Oxfendazole as a Macrofilaricidal Drug in Adults Harbouring Lymphatic Filarial Worms.Infectious diseases and therapy · 2026Article
- Population pharmacokinetic-pharmacodynamic modeling of clopidogrel for dose regimen optimization based on CYP2C19 phenotypes: A proof of concept study.CPT: pharmacometrics & systems pharmacology · 2024Article
- Population Pharmacokinetic-Pharmacodynamic Model of Oxfendazole in Healthy Adults in a Multiple Ascending Dose and Food Effect Study and Target Attainment Analysis.Antimicrobial agents and chemotherapy · 2022Article
- Comparing the performance of first-order conditional estimation (FOCE) and different expectation-maximization (EM) methods in NONMEM: real data experience with complex nonlinear parent-metabolite pharmacokinetic model.Journal of pharmacokinetics and pharmacodynamics · 2021Article
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
Abstract
Oxfendazole is a potent veterinary benzimidazole anthelmintic under transition to humans for the treatment of multiple parasitic infectious diseases. The first-in-human study evaluating the disposition of oxfendazole and its metabolites in healthy adults following single ascending oral doses from 0.5 to 60 mg/kg of body weight shows that oxfendazole pharmacokinetics is substantially nonlinear, which complicates correlating oxfendazole dose to exposure. To quantitatively capture the relation between oxfendazole dose and exposure, a population pharmacokinetic model for oxfendazole and its metabolites, oxfendazole sulfone and fenbendazole, in humans was developed using a nonlinear mixed-effect modeling approach. Our final model incorporated mechanistic characterization of dose-limited bioavailability as well as different oxfendazole metabolic processes and provided insight into the significance of presystemic metabolism in oxfendazole and metabolite disposition. Oxfendazole clinical pharmacokinetics was best described by a one-compartment model with nonlinear absorption and linear elimination. Oxfendazole apparent clearance and apparent volume of distribution were estimated to be 2.57 liters/h and 35.2 liters, respectively, at the lowest dose (0.5 mg/kg), indicating that oxfendazole is a low extraction drug with moderate distribution. The disposition of both metabolites was adequately characterized by a one-compartment model with formation rate-limited elimination. Fenbendazole formation from oxfendazole was primarily through systemic metabolism, while both presystemic and systemic metabolism were critical to the formation of oxfendazole sulfone. Our model adequately captured the concentration-time profiles of both oxfendazole and its two metabolites in healthy adults over a wide dose range. The model can be used to predict oxfendazole disposition under new dosing regimens to support dose optimization in humans.
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