A Dose-Confirmation Phase 1 Study to Evaluate the Safety and Pharmacology of Glucarpidase in Healthy Volunteers.
Sign Up to like & getrecommendations! Published in 2021 at "Clinical pharmacology in drug development"
DOI: 10.1002/cpdd.1010
Abstract: Glucarpidase rapidly decomposes methotrexate. A phase 1 study of glucarpidase in an open-label, randomized parallel group was conducted to evaluate the safety, pharmacokinetics, and other pharmacologic effects in Japanese healthy volunteers without methotrexate treatment. A… read more here.
Keywords: glucarpidase; pharmacology; evaluate safety; phase study ... See more keywords
MTXPK.org: A Clinical Decision Support Tool Evaluating High‐Dose Methotrexate Pharmacokinetics to Inform Post‐Infusion Care and Use of Glucarpidase
Sign Up to like & getrecommendations! Published in 2020 at "Clinical Pharmacology and Therapeutics"
DOI: 10.1002/cpt.1957
Abstract: Methotrexate (MTX), an antifolate, is administered at high doses to treat malignancies in children and adults. However, there is considerable interpatient variability in clearance of high‐dose (HD) MTX. Patients with delayed clearance are at an… read more here.
Keywords: glucarpidase; support tool; decision support; mtx ... See more keywords
Therapeutic Drug Monitoring of Methotrexate in Plasma Using Ultra High-Performance Liquid Chromatography-Electrospray Ionization-Tandem Mass Spectrometry: Necessary After Administration of Glucarpidase in Methotrexate Intoxications.
Sign Up to like & getrecommendations! Published in 2018 at "Therapeutic Drug Monitoring"
DOI: 10.1097/ftd.0000000000000515
Abstract: High-dose methotrexate (HD-MTX) is used to treat a variety of cancers. In all patients receiving HD-MTX, plasma MTX levels are monitored mainly to anticipate rescue therapy to prevent adverse events. We present 2 children treated… read more here.
Keywords: glucarpidase; administration; methotrexate; administration glucarpidase ... See more keywords
Pharmacokinetics and Pharmacodynamics of Glucarpidase Rescue Treatment After High-dose Methotrexate Therapy Based on Modeling and Simulation
Sign Up to like & getrecommendations! Published in 2023 at "AntiCancer Research"
DOI: 10.21873/anticanres.16351
Abstract: Background: Model-informed approaches are important in drug development, including for dose optimization and the collection of evidence in support of efficacy. Materials and Methods: We developed a modified Michaelis–Menten pharmacokinetics/pharmacodynamics model and used it to… read more here.
Keywords: rescue treatment; pharmacokinetics pharmacodynamics; concentration; methotrexate ... See more keywords
Development of a population pharmacokinetics and pharmacodynamics model of glucarpidase rescue treatment after high-dose methotrexate therapy
Sign Up to like & getrecommendations! Published in 2023 at "Frontiers in Oncology"
DOI: 10.3389/fonc.2023.1003633
Abstract: Introduction Glucarpidase (CPG2) reduces the lethal toxicity of methotrexate (MTX) by rapid degradation. Methods In this study, a CPG2 population pharmacokinetics (popPK) analysis in healthy volunteers (phase 1 study) and a popPK-pharmacodynamics (popPK-PD) analysis in… read more here.
Keywords: cpg2; mtx; methotrexate; population pharmacokinetics ... See more keywords