Determinants of gefitinib pharmacokinetics in healthy Chinese male subjects: A pharmacogenomic study of cytochrome p450 enzymes and transporters.

What is known and objective: Gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, exhibited a wide interindividual variability in pharmacokinetics. In the present study, we aimed to evaluate the impact of single‐nucleotide polymorphisms in the metabolizing enzymes and tra...

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Publicado en:Journal of Clinical Pharmacy & Therapeutics Vol. 45; no. 5; pp. 1159 - 1168
Autores principales: Wan, Zirui, Guo, Lifang, Li, Pengfei, Zhao, Zhixia, Xu, Benshan, Ren, Lulu, Yan, Yan, Liu, He, Zhang, Yiwen, Liu, Lihong
Formato: research tables/charts Journal Article
Publicado: Wiley-Blackwell Oct2020
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Oct2020
      vid: 45
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        10.1111/jcpt.13168
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        atl: Determinants of gefitinib pharmacokinetics in healthy Chinese male subjects: A pharmacogenomic study of cytochrome p450 enzymes and transporters.
      aug:
        au:
          Wan, Zirui
          Guo, Lifang
          Li, Pengfei
          Zhao, Zhixia
          Xu, Benshan
          Ren, Lulu
          Yan, Yan
          Liu, He
          Zhang, Yiwen
          Liu, Lihong
        affil: Pharmacy Department of Beijing Chao‐Yang Hospital, Capital Medical University, Beijing, China
      sug:
        subj:
          Gefitinib Pharmacokinetics
          Pharmacogenetics
          Polymorphism, Single Nucleotide
          Cytochrome P-450 Enzyme System Metabolism
          Carrier Proteins Metabolism
          Men's Health
          Chinese Persons
          Human
          Sequence Analysis
          Chromatography, Liquid
          Mass Spectrometry
          Unpaired T-Tests
          Mann-Whitney U Test
          Step-Wise Multiple Regression
          Multiple Linear Regression
          Tyrosine Kinase Inhibitors
          Alleles
          Descriptive Statistics
      ab: What is known and objective: Gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, exhibited a wide interindividual variability in pharmacokinetics. In the present study, we aimed to evaluate the impact of single‐nucleotide polymorphisms in the metabolizing enzymes and transporters on gefitinib disposition in healthy Chinese subjects. Methods: Fourteen single‐nucleotide polymorphisms, including polymorphisms of ATP‐binding cassette (ABC) transporters and cytochrome P450 enzymes, were genotyped by Sanger sequencing, and the concentration of gefitinib was measured by ultrafast liquid chromatography‐tandem mass spectrometry. The association between the pharmacokinetic parameters (peak plasma concentration [Cmax], time to reach Cmax, plasma half‐life, area under the concentration‐time curve from 0 to 168 hours [AUC(0‐168h)], AUC(0‐∞) and plasma clearance [CL/F]) and genotypes was evaluated using unpaired t test or Mann‐Whitney U test. A stepwise multiple linear regression analysis was applied to assess the relationships between multiple factors and gefitinib pharmacokinetics. Thirty‐nine healthy Chinese male subjects were enrolled in the pharmacokinetic study. Results and discussion: Subjects carrying an ABCG2 A allele (c.421CA + c.421AA genotypes) exhibited 33 and 37% increases in the mean gefitinib AUC(0‐168h) and AUC(0‐∞) values (P <.05), respectively, compared to that of subjects carrying wild‐type ABCG2 (c.421CC). Additionally, the mean CL/F of the c.421A allele carriers was 32% less than that of the c.421CC carriers (P <.05). No associations were found between polymorphisms in other metabolic enzymes or ABC transporters and gefitinib pharmacokinetics. What is new and conclusion: Our results suggested that a single‐nucleotide polymorphism in ABCG2 (c.421C>A) significantly affected the pharmacokinetics of gefitinib. Further studies are required to evaluate the effects of single‐nucleotide polymorphism on the pharmacokinetics, pharmacodynamics and toxicity of gefitinib.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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