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Abstract

Background: A LC–MS/MS method was validated for the quantification of SUVN-G3031, a novel H3 receptor inverse agonist in clinical development for the treatment of patients with narcolepsy, with and without cataplexy. Methodology: SUVN-G3031 was extracted from plasma following acetonitrile protein precipitation, separated by Ultra HPLC and quantified using positive ESI–MS/MS. Results: The method was linear across the range of 0.1–100 ng ml-1 in plasma. Results for intra and inter-day accuracy were from 99.8 to 104% and precision (%CV) was ≤10.6%. Conclusion: The method was applied to a first-in-human study in healthy volunteers. The method is precise, accurate and highly selective for the quantification of SUVN-G3031 in human plasma.

Keywords:

  • bioanalysis
  • cataplexy
  • clinical
  • H3 receptor
  • LC–MS
  • narcolepsy
  • sleep
  • SUVN-G3031
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