The safety, tolerability, PK and PD of GSK2339345 in healthy subjects

• Research type

  Research Study

• Full title

  A two part study to investigate the safety and tolerability, pharmacokinetics and pharmacodynamics of GSK2339345 in healthy subjects. Part A: an open label, dose escalating, rinse, gargle and spit study. Part B: a randomised, double-blind, placebo controlled, inhaled dose escalating study using nebulised lidocaine for blinding purposes.

• IRAS ID

  86314

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2011-002582-38

• Research summary

  The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of GSK2339345 in healthy subjects.Part A of this study will be conducted in healthy volunteers to investigate the safety and tolerability of GSK2339345, in particular examining oropharyngeal sensation perturbation. Part A is an open label, oral, single-dose escalating rinse, gargle and spit study. Assessments of sensate changes will include 4 point scale, assessment of sensation on base of tongue, sensation of temperature, assessment of taste, a water swallow test and assessment of potential paraesthesias. Part A will also include PK assessments to investigate the PK profile of GSK2339345.Part B of this study is a randomised, double blind, placebo controlled, inhaled dose escalation study over two study days per dose to examine the possible adverse events such as transient mouth, throat and upper airway numbness in healthy volunteers. Similar assessments of sensations to those used in Part A will be performed. The potential for systemic cardiovascular (CV) or central nervous system (CNS) effects will also be assessed. Pharmacodynamic effects of GSK2339345 will be investigated in Part B using a capsaicin cough challenge. The study will investigate whether GSK2339345 can alter the capsaicin cough threshold (as determined by the capsaicin concentration required to induce 2 or more (C2) and 5 or more (C5) coughs) in healthy volunteers. Part B will also include PK assessments to investigate the PK profile of GSK2339345. Placebo will be used as a control and nebulised lidocaine will be used for control and blinding purposes only.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/NW/0625

• Date of REC Opinion

  29 Sep 2011

• REC opinion

  Further Information Favourable Opinion