A small-animal pharmacokinetic/pharmacodynamic PET study of central serotonin 1A receptor occupancy by a potential therapeutic agent for overactive bladder

PLoS One. 2013 Sep 23;8(9):e75040. doi: 10.1371/journal.pone.0075040. eCollection 2013.

Abstract

Serotonin 1A (5-HT1A) receptors have been mechanistically implicated in micturition control, and there has been a need for an appropriate biomarker surrogating the potency of a provisional drug acting on this receptor system for developing a new therapeutic approach to overactive bladder (OAB). Here, we analyzed the occupancy of 5-HT1A receptors in living Sprague-Dawley rat brains by a novel candidate drug for OAB, E2110, using positron emission tomography (PET) imaging, and assessed the utility of a receptor occupancy (RO) assay to establish a pharmacodynamic index translatable between animals and humans. The plasma concentrations inducing 50% RO (EC50) estimated by both direct and effect compartment models were in good agreement. Dose-dependent therapeutic effects of E2110 on dysregulated micturition in different rat models of pollakiuria were also consistently explained by achievement of 5-HT1A RO by E2110 in a certain range (≥ 60%). Plasma drug concentrations inducing this RO range and EC50 would accordingly be objective indices in comparing pharmacokinetics-RO relationships between rats and humans. These findings support the utility of PET RO and plasma pharmacokinetic assays with the aid of adequate mathematical models in determining the in vivo characteristics of a drug acting on 5-HT1A receptors and thereby counteracting OAB.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • 8-Hydroxy-2-(di-n-propylamino)tetralin / administration & dosage
  • 8-Hydroxy-2-(di-n-propylamino)tetralin / pharmacology
  • Administration, Oral
  • Animals
  • Computer Simulation
  • Hippocampus / drug effects
  • Hippocampus / metabolism
  • Microsomes / drug effects
  • Microsomes / metabolism
  • Piperidines / chemistry
  • Piperidines / pharmacokinetics*
  • Piperidines / pharmacology*
  • Piperidines / therapeutic use
  • Positron-Emission Tomography*
  • Protein Binding / drug effects
  • Rats
  • Rats, Sprague-Dawley
  • Receptor, Serotonin, 5-HT1A / metabolism*
  • Reflex / drug effects
  • Superior Colliculi / drug effects
  • Time Factors
  • Urinary Bladder, Overactive / diagnostic imaging*
  • Urinary Bladder, Overactive / drug therapy*
  • Urinary Bladder, Overactive / physiopathology
  • Urination / drug effects

Substances

  • Piperidines
  • Receptor, Serotonin, 5-HT1A
  • piperidine
  • 8-Hydroxy-2-(di-n-propylamino)tetralin

Grants and funding

This work was supported in part by Grants-in-Aid for Japan Advanced Molecular Imaging Program from the Ministry of Education, Culture, Sports, Science and Technology, Japan. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.