Omura Koichi, Nakazawa Takashi, Sato Takahiro, Iwanaga Takashi, Nagata Osamu
Research Laboratories 2, Fuji Yakuhin Co Ltd, Saitama, Japan.
Drug Metab Dispos. 2007 Dec;35(12):2143-8. doi: 10.1124/dmd.107.017251. Epub 2007 Aug 30.
In humans, orally administered 4-(5-pyridin-4-yl-1H-[1,2,4]triazol-3-yl) pyridine-2-carbonitrile (FYX-051) is excreted mainly as triazole N(1)- and N(2)-glucuronides in urine. It is important to determine the enzyme(s) that catalyze the metabolism of a new drug to estimate individual differences and/or drug-drug interactions. Therefore, the characterization and mechanism of these glucuronidations were investigated using human liver microsomes (HLMs), human intestinal microsomes (HIMs), and recombinant human UDP-glucuronosyltransferase (UGT) isoforms to determine the UGT isoform(s) responsible for FYX-051 N(1)- and N(2)-glucuronidation. FYX-051 was metabolized to its N(1)- and N(2)-glucuronide forms by HLMs, and their K(m) values were 64.1 and 72.7 microM, respectively; however, FYX-051 was scarcely metabolized to its glucuronides by HIMs. Furthermore, among the recombinant human UGT isoforms, UGT1A1, UGT1A7, and UGT1A9 catalyzed the N(1)- and N(2)-glucuronidation of FYX-051. To estimate their contribution to FYX-051 glucuronidation, inhibition analysis with pooled HLMs was performed. Mefenamic acid, a UGT1A9 inhibitor, decreased FYX-051 N(1)- and N(2)-glucuronosyltransferase activities, whereas bilirubin, a UGT1A1 inhibitor, did not affect these activities. Furthermore, in the experiment using microsomes from eight human livers, the N(1)- and N(2)-glucuronidation activity of FYX-051 was found to significantly correlate with the glucuronidation activity of propofol, a specific substrate of UGT1A9 (N(1): r(2) = 0.868, p < 0.01; N(2): r(2) = 0.775, p < 0.01). These results strongly suggested that the N(1)- and N(2)-glucuronidation of FYX-051 is catalyzed mainly by UGT1A9 in human livers.
在人体中,口服4-(5-吡啶-4-基-1H-[1,2,4]三唑-3-基)吡啶-2-甲腈(FYX-051)后,主要以三唑N(1)-和N(2)-葡萄糖醛酸苷的形式经尿液排泄。确定催化新药代谢的酶对于评估个体差异和/或药物相互作用很重要。因此,利用人肝微粒体(HLM)、人肠微粒体(HIM)和重组人尿苷二磷酸葡萄糖醛酸基转移酶(UGT)同工型研究了这些葡萄糖醛酸化反应的特征和机制,以确定负责FYX-051 N(1)-和N(2)-葡萄糖醛酸化反应的UGT同工型。FYX-051被HLM代谢为其N(1)-和N(2)-葡萄糖醛酸苷形式,其米氏常数(K(m))值分别为64.1和72.7 microM;然而,FYX-051几乎不被HIM代谢为其葡萄糖醛酸苷。此外,在重组人UGT同工型中,UGT1A1、UGT1A7和UGT1A9催化FYX-051的N(1)-和N(2)-葡萄糖醛酸化反应。为评估它们对FYX-051葡萄糖醛酸化反应的贡献,进行了混合HLM的抑制分析。UGT1A9抑制剂甲芬那酸降低了FYX-051 N(1)-和N(2)-葡萄糖醛酸基转移酶活性,而UGT1A1抑制剂胆红素对这些活性没有影响。此外,在使用来自八个人肝脏的微粒体进行的实验中,发现FYX-051的N(1)-和N(2)-葡萄糖醛酸化活性与UGT1A9的特异性底物丙泊酚的葡萄糖醛酸化活性显著相关(N(1):r(2)=0.868,p<0.01;N(2):r(2)=0.775,p<0.01)。这些结果强烈表明,FYX-051的N(1)-和N(2)-葡萄糖醛酸化反应主要由人肝脏中的UGT1A9催化。