| Effect of food on the pharmacokinetics of sunitinib malate (SU11248), a multi-targeted receptor tyrosine kinase inhibitor: results from a phase I study in healthy subjects. | |
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MedLine Citation:
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PMID: 16520665 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The effect of food on the oral bioavailability of sunitinib malate (SU11248, an oral, multi-targeted tyrosine kinase inhibitor with anti-angiogenic and anti-tumor activities) was assessed in a randomized open-label, two-way crossover study. A 50-mg dose of SU11248 was administered to 16 healthy subjects after a 10-h fast in one period and after a high-fat, high-calorie meal in the other period. The 90% confidence intervals (CIs) for maximum plasma concentration (Cmax) and area under the concentration-time curve (AUC) were within the 80-125% bioequivalence range, indicating the absence of a food effect. SU11248 exposure increased slightly in the fed compared with the fasted state (ratios of fed/fasted geometric least square means: Cmax 104%, AUC0-last and AUC0-infinity both 112%). There was a delay in the formation/absorption of the active metabolite SU12662 in the fed state (mean Cmax decreased 23%), but exposure remained unaffected (90% CIs for AUC0-last and AUC0-infinity were within 80-125%). These results indicate that SU11248 can be administered with or without food. |
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Authors:
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Carlo L Bello; Laurie Sherman; Jihao Zhou; Lev Verkh; John Smeraglia; Janessa Mount; Karen J Klamerus |
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Publication Detail:
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Type: Clinical Trial, Phase I; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Anti-cancer drugs Volume: 17 ISSN: 0959-4973 ISO Abbreviation: Anticancer Drugs Publication Date: 2006 Mar |
Date Detail:
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Created Date: 2006-03-07 Completed Date: 2006-12-04 Revised Date: 2009-11-19 |
Medline Journal Info:
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Nlm Unique ID: 9100823 Medline TA: Anticancer Drugs Country: England |
Other Details:
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Languages: eng Pagination: 353-8 Citation Subset: IM |
Affiliation:
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Department of Clinical Pharmacology, Pfizer Global Research and Development, La Jolla, California 92121, USA. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Biological Availability Cross-Over Studies Female Food-Drug Interactions* Humans Indoles / adverse effects, blood, pharmacokinetics* Male Middle Aged Protein-Tyrosine Kinases / antagonists & inhibitors*, metabolism Pyrroles / adverse effects, blood, pharmacokinetics* |
| Chemical | |
Reg. No./Substance:
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0/Indoles; 0/Pyrroles; 0/SU 12662; 0/sunitinib; EC 2.7.10.1/Protein-Tyrosine Kinases |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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