| Pharmacokinetics of glucarpidase in subjects with normal and impaired renal function. | |
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MedLine Citation:
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PMID: 18192538 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Glucarpidase (formerly known as carboxypeptidase G2 or CPG2) is being evaluated for the adjunctive treatment of patients experiencing, or at risk of, methotrexate toxicity attributable to its delayed elimination. Delayed elimination of methotrexate can occur in patients with methotrexate-induced renal toxicity. In this study, glucarpidase pharmacokinetics were assessed in volunteer subjects with normal (n = 8) and severely impaired (n = 4) renal function. Each subject received a single intravenous dose of glucarpidase 50 U/kg (equivalent to 114.5 microg/kg) infused over 5 minutes. The mean maximum serum concentration (C(max)) for glucarpidase in renally impaired subjects was 2.9 microg/mL, the mean half-life (t(1/2)) was 10.0 hours, and the mean area under the serum concentration-time curve from time zero to infinity (AUC(0-infinity)) was 24.5 microg x h/mL. Similar values were found in subjects with normal renal function (mean C(max) 3.1 microg/mL, mean t(1/2) 9.0 hours, and mean AUC(0-infinity) 23.4 microg x h/mL). The results indicated little effect of renal impairment on the serum pharmacokinetics of glucarpidase. |
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Authors:
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Marc Phillips; William Smith; Guhan Balan; Suzanne Ward |
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Publication Detail:
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Type: Clinical Trial; Journal Article Date: 2008-01-11 |
Journal Detail:
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Title: Journal of clinical pharmacology Volume: 48 ISSN: 0091-2700 ISO Abbreviation: J Clin Pharmacol Publication Date: 2008 Mar |
Date Detail:
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Created Date: 2008-02-20 Completed Date: 2008-05-19 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0366372 Medline TA: J Clin Pharmacol Country: United States |
Other Details:
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Languages: eng Pagination: 279-84 Citation Subset: IM |
Affiliation:
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Protherics PLC, The Heath Business & Technical Park, Runcorn, Cheshire, UK. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Analysis of Variance Area Under Curve Enzyme-Linked Immunosorbent Assay Female Half-Life Humans Injections, Intravenous Kidney / metabolism* Kidney Diseases / drug therapy, metabolism*, physiopathology Male Metabolic Clearance Rate Middle Aged gamma-Glutamyl Hydrolase / administration & dosage, blood, pharmacokinetics* |
| Chemical | |
Reg. No./Substance:
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EC 3.4.19.9/gamma-Glutamyl Hydrolase |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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