Elucidating the mechanism of cytochrome P450-mediated pyrimidine ring conversion to pyrazole metabolites with the BACE1 inhibitor GNE-892 in rats

Drug Metab Dispos. 2014 May;42(5):890-8. doi: 10.1124/dmd.114.057141. Epub 2014 Mar 4.

Abstract

We investigated an uncommon biotransformation of pyrimidine during the metabolism of GNE-892 ((R)-2-amino-1,3',3'-trimethyl-7'-(pyrimidin-5-yl)-3',4'-dihydro-2'H-spiro[imidazole-4,1'-naphthalen]-5(1H)-one), a β-secretase 1 inhibitor. Three novel metabolites, formed by conversion of pyrimidine to pyrazole, were observed in the (14)C-radiolabeled mass balance study in rats. Their structures were characterized by high-resolution mass spectrometry and nuclear magnetic resonance. Although these metabolites accounted for <5% of the administered dose, their unique nature prompted us to conduct further investigations. The pyrazole-containing metabolites were formed in vitro with rat hepatocytes and liver microsomes, which supported that they were formed during hepatic metabolism. Further, their generation was inhibited by 1-aminobenzotriazole, indicating involvement of cytochrome P450s. Studies with rat recombinant enzymes identified that CYP2D2 generated the N-hydroxypyrazole metabolite from GNE-892. This biotransformation proceeded through multiple steps from the likely precursor, pyrimidine N-oxide. On the basis of these data, we propose a mechanism in which the pyrimidine is activated via N-oxidation, followed by a second oxidative process that opens the pyrimidine ring to form a formamide intermediate. After hydrolysis of the formamide, a carbon is lost as formic acid, together with ring closure to form the pyrazole ring. This article highlights a mechanistic approach for determining the biotransformation of the pyrimidine to a pyrazole for GNE-892.

MeSH terms

  • Amyloid Precursor Protein Secretases / antagonists & inhibitors*
  • Animals
  • Aryl Hydrocarbon Hydroxylases / metabolism*
  • Aspartic Acid Endopeptidases / antagonists & inhibitors*
  • Bile / metabolism
  • Biotransformation
  • Cells, Cultured
  • Chromatography, High Pressure Liquid
  • Enzyme Inhibitors / metabolism*
  • Enzyme Inhibitors / pharmacokinetics
  • Enzyme Inhibitors / urine
  • Feces / chemistry
  • Hepatocytes / drug effects
  • Hepatocytes / enzymology
  • Imidazoles / metabolism*
  • Imidazoles / pharmacokinetics
  • Imidazoles / urine
  • Male
  • Pyrazoles / metabolism*
  • Pyrimidines / metabolism*
  • Rats
  • Rats, Sprague-Dawley
  • Spiro Compounds / metabolism*
  • Spiro Compounds / pharmacokinetics
  • Spiro Compounds / urine
  • Tandem Mass Spectrometry

Substances

  • 2-amino-1,3',3'-trimethyl-7'-(pyrimidin-5-yl)-3',4'-dihydro-2'H-spiro(imidazole-4,1'-naphthalen)-5(1H)-one
  • Enzyme Inhibitors
  • Imidazoles
  • Pyrazoles
  • Pyrimidines
  • Spiro Compounds
  • pyrazole
  • Aryl Hydrocarbon Hydroxylases
  • Cyp2d2 protein, rat
  • Amyloid Precursor Protein Secretases
  • Aspartic Acid Endopeptidases
  • Bace1 protein, rat
  • pyrimidine