Comparative biotransformation of pyrazinone-containing corticotropin-releasing factor receptor-1 antagonists: minimizing the reactive metabolite formation

Drug Metab Dispos. 2010 Jan;38(1):5-15. doi: 10.1124/dmd.109.028910.

Abstract

(S)-5-Chloro-1-(1-cyclopropylethyl)-3-(2,6-dichloro-4-(trifluoromethyl)phenylamino)pyrazin-2(1H)-one (BMS-665053), a pyrazinone-containing compound, is a potent and selective antagonist of corticotropin-releasing factor receptor-1 (CRF-R1) that showed efficacy in the defensive withdrawal model for anxiety in rats, suggesting its use as a potential treatment for anxiety and depression. In vitro metabolism studies of BMS-665053 in rat and human liver microsomes revealed cytochrome P450-mediated oxidation of the pyrazinone moiety, followed by ring opening, as the primary metabolic pathway. Detection of a series of GSH adducts in trapping experiments suggested the formation of a reactive intermediate, probably as a result of epoxidation of the pyrazinone moiety. In addition, BMS-665053 (20 mg/kg i.v.) underwent extensive metabolism in bile duct-cannulated (BDC) rats. The major drug-related materials in rat plasma were the pyrazinone oxidation products. In rat bile and urine (0-7 h), only a trace amount of the parent drug was recovered, whereas significant levels of the pyrazinone epoxide-derived metabolites and GSH-related conjugates were detected. Further evidence suggested that GSH-related conjugates also formed at the dichloroarylamine moiety possibly via an epoxide or a quinone imine intermediate. Other major metabolites in BDC rat bile and urine included glucuronide conjugates. To reduce potential liability due to metabolic activation of BMS-665053, a number of pyrazinone analogs with different substituents were synthesized and investigated for reactive metabolite formation, leading to the discovery of a CRF-R1 antagonist with diminished in vitro metabolic activation.

Publication types

  • Comparative Study

MeSH terms

  • Animals
  • Bile / chemistry
  • Biotransformation
  • Glucuronic Acid / metabolism
  • Glutathione / metabolism
  • Humans
  • Liver / enzymology
  • Magnetic Resonance Spectroscopy
  • Male
  • Mass Spectrometry
  • Microsomes, Liver / enzymology
  • Models, Chemical
  • Molecular Structure
  • Pyrazines / blood
  • Pyrazines / chemistry*
  • Pyrazines / metabolism
  • Pyrazines / urine
  • Rats
  • Rats, Sprague-Dawley
  • Receptors, Corticotropin-Releasing Hormone / antagonists & inhibitors*
  • Spectrophotometry, Ultraviolet

Substances

  • BMS 665053
  • Pyrazines
  • Receptors, Corticotropin-Releasing Hormone
  • CRF receptor type 1
  • Glucuronic Acid
  • Glutathione