Discovery of two clinical histamine H(3) receptor antagonists: trans-N-ethyl-3-fluoro-3-[3-fluoro-4-(pyrrolidinylmethyl)phenyl]cyclobutanecarboxamide (PF-03654746) and trans-3-fluoro-3-[3-fluoro-4-(pyrrolidin-1-ylmethyl)phenyl]-N-(2-methylpropyl)cyclobutanecarboxamide (PF-03654764)

J Med Chem. 2011 Nov 10;54(21):7602-20. doi: 10.1021/jm200939b. Epub 2011 Oct 7.

Abstract

The discovery of two histamine H(3) antagonist clinical candidates is disclosed. The pathway to identification of the two clinical candidates, 6 (PF-03654746) and 7 (PF-03654764) required five hypothesis driven design cycles. The key to success in identifying these clinical candidates was the development of a compound design strategy that leveraged medicinal chemistry knowledge and traditional assays in conjunction with computational and in vitro safety tools. Overall, clinical compounds 6 and 7 exceeded conservative safety margins and possessed optimal pharmacological and pharmacokinetic profiles, thus achieving our initial goal of identifying compounds with fully aligned oral drug attributes, "best-in-class" molecules.

MeSH terms

  • Animals
  • Blood Proteins / metabolism
  • Blood-Brain Barrier / metabolism
  • Cell Line
  • Cyclobutanes / chemical synthesis*
  • Cyclobutanes / pharmacology
  • Cyclobutanes / toxicity
  • Dogs
  • Drinking Behavior / drug effects
  • Drug Design*
  • High-Throughput Screening Assays
  • Histamine Antagonists / chemical synthesis*
  • Histamine Antagonists / pharmacology
  • Histamine Antagonists / toxicity
  • Humans
  • In Vitro Techniques
  • Kidney / metabolism
  • Lipidoses / chemically induced
  • Lipidoses / metabolism
  • Lung / metabolism
  • Microsomes, Liver / drug effects
  • Microsomes, Liver / metabolism
  • Models, Molecular
  • Molecular Structure
  • Phospholipids / metabolism
  • Protein Binding
  • Pyrrolidines / chemical synthesis*
  • Pyrrolidines / pharmacology
  • Pyrrolidines / toxicity
  • Rats
  • Rats, Sprague-Dawley
  • Receptors, Histamine H3 / metabolism*
  • Stereoisomerism
  • Structure-Activity Relationship

Substances

  • 3-fluoro-3-(3-fluoro-4-(pyrrolidin-1-ylmethyl)phenyl)-N-(2-methylpropyl)cyclobutanecarboxamide
  • Blood Proteins
  • Cyclobutanes
  • Histamine Antagonists
  • N-ethyl-3-fluoro-3-(3-fluoro-4-(pyrrolidinylmethyl)phenyl)cyclobutanecarboxamide
  • Phospholipids
  • Pyrrolidines
  • Receptors, Histamine H3