Document Detail


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.
MedLine Citation:
PMID:  16520665     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Carlo L Bello; Laurie Sherman; Jihao Zhou; Lev Verkh; John Smeraglia; Janessa Mount; Karen J Klamerus
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Anti-cancer drugs     Volume:  17     ISSN:  0959-4973     ISO Abbreviation:  Anticancer Drugs     Publication Date:  2006 Mar 
Date Detail:
Created Date:  2006-03-07     Completed Date:  2006-12-04     Revised Date:  2009-11-19    
Medline Journal Info:
Nlm Unique ID:  9100823     Medline TA:  Anticancer Drugs     Country:  England    
Other Details:
Languages:  eng     Pagination:  353-8     Citation Subset:  IM    
Affiliation:
Department of Clinical Pharmacology, Pfizer Global Research and Development, La Jolla, California 92121, USA.
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MeSH Terms
Descriptor/Qualifier:
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:
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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