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Research ArticleDrug Discovery and Translational Medicine

Inhibition of TRPM8 Channels Reduces Pain in the Cold Pressor Test in Humans

Wendy J. Winchester, Katrina Gore, Sophie Glatt, Wendy Petit, Jennifer C. Gardiner, Kelly Conlon, Michael Postlethwaite, Pierre-Philippe Saintot, Sonia Roberts, James R. Gosset, Tomomi Matsuura, Mark D. Andrews, Paul A. Glossop, Michael J. Palmer, Nicola Clear, Susie Collins, Kevin Beaumont and David S. Reynolds
Journal of Pharmacology and Experimental Therapeutics November 2014, 351 (2) 259-269; DOI: https://doi.org/10.1124/jpet.114.216010
Wendy J. Winchester
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Katrina Gore
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Sophie Glatt
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Wendy Petit
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Jennifer C. Gardiner
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Kelly Conlon
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Michael Postlethwaite
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Pierre-Philippe Saintot
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Sonia Roberts
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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James R. Gosset
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Tomomi Matsuura
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Mark D. Andrews
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Paul A. Glossop
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Michael J. Palmer
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Nicola Clear
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Susie Collins
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Kevin Beaumont
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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David S. Reynolds
Pfizer Limited, Neusentis Research Unit, Granta Park, Cambridge, United Kingdom (W.J.W., K.G., S.G., D.S.R.); Genito-Urinary Research Unit (W.J.W., J.C.G., K.C., M.P., P.-P.S., D.S.R.), Research Statistics (K.G., S.C.), Drug Safety, Research and Development (S.R.), Pharmacokinetics, Dynamics and Metabolism (J.R.G., T.M., K.B.), and Worldwide Medicinal Chemistry (M.D.A., P.A.G., M.J.P.), Pfizer Global Research and Development, Sandwich, Kent, United Kingdom; Pfizer Clinical Research Unit, Lenniksebaan, Brussels, Belgium (W.P.); and PharmaTherapeutics Pharmaceutical Sciences, Pfizer Limited, Sandwich, United Kingdom (N.C.)
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Abstract

The transient receptor potential (subfamily M, member 8; TRPM8) is a nonselective cation channel localized in primary sensory neurons, and is a candidate for cold thermosensing, mediation of cold pain, and bladder overactivity. Studies with TRPM8 knockout mice and selective TRPM8 channel blockers demonstrate a lack of cold sensitivity and reduced cold pain in various rodent models. Furthermore, TRPM8 blockers significantly lower body temperature. We have identified a moderately potent (IC50 = 103 nM), selective TRPM8 antagonist, PF-05105679 [(R)-3-[(1-(4-fluorophenyl)ethyl)(quinolin-3-ylcarbonyl)amino]methylbenzoic acid]. It demonstrated activity in vivo in the guinea pig bladder ice water and menthol challenge tests with an IC50 of 200 nM and reduced core body temperature in the rat (at concentrations >1219 nM). PF-05105679 was suitable for acute administration to humans and was evaluated for effects on core body temperature and experimentally induced cold pain, using the cold pressor test. Unbound plasma concentrations greater than the IC50 were achieved with 600- and 900-mg doses. The compound displayed a significant inhibition of pain in the cold pressor test, with efficacy equivalent to oxycodone (20 mg) at 1.5 hours postdose. No effect on core body temperature was observed. An unexpected adverse event (hot feeling) was reported, predominantly periorally, in 23 and 36% of volunteers (600- and 900-mg dose, respectively), which in two volunteers was nontolerable. In conclusion, this study supports a role for TRPM8 in acute cold pain signaling at doses that do not cause hypothermia.

Footnotes

    • Received April 28, 2014.
    • Accepted August 13, 2014.
  • This work was funded by Pfizer Ltd.

  • dx.doi.org/10.1124/jpet.114.216010.

  • Copyright © 2014 by The American Society for Pharmacology and Experimental Therapeutics
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Journal of Pharmacology and Experimental Therapeutics: 351 (2)
Journal of Pharmacology and Experimental Therapeutics
Vol. 351, Issue 2
1 Nov 2014
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Research ArticleDrug Discovery and Translational Medicine

TRPM8 Antagonism Reduces Experimental Cold Pain in Humans

Wendy J. Winchester, Katrina Gore, Sophie Glatt, Wendy Petit, Jennifer C. Gardiner, Kelly Conlon, Michael Postlethwaite, Pierre-Philippe Saintot, Sonia Roberts, James R. Gosset, Tomomi Matsuura, Mark D. Andrews, Paul A. Glossop, Michael J. Palmer, Nicola Clear, Susie Collins, Kevin Beaumont and David S. Reynolds
Journal of Pharmacology and Experimental Therapeutics November 1, 2014, 351 (2) 259-269; DOI: https://doi.org/10.1124/jpet.114.216010

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Research ArticleDrug Discovery and Translational Medicine

TRPM8 Antagonism Reduces Experimental Cold Pain in Humans

Wendy J. Winchester, Katrina Gore, Sophie Glatt, Wendy Petit, Jennifer C. Gardiner, Kelly Conlon, Michael Postlethwaite, Pierre-Philippe Saintot, Sonia Roberts, James R. Gosset, Tomomi Matsuura, Mark D. Andrews, Paul A. Glossop, Michael J. Palmer, Nicola Clear, Susie Collins, Kevin Beaumont and David S. Reynolds
Journal of Pharmacology and Experimental Therapeutics November 1, 2014, 351 (2) 259-269; DOI: https://doi.org/10.1124/jpet.114.216010
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