Two part study investigating the effects of SB-705498 in chronic cough

• Research type

  Research Study

• Full title

  A two part study to investigate the pharmacokinetics and pharmacodynamics of SB-705498, a TRPV1 antagonist, in cough. Part A: an open label study in healthy subjects to determine the exposure to SB-705498. Part B: a randomized, double-blind, placebo controlled, cross over study to investigate the effects of SB-705498 on capsaicin-induced cough and 24 hour cough counts in patients with chronic cough

• IRAS ID

  70649

• Contact name

  Ashley Woodcock

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2010-021642-22

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study aims to assess the effects of a single oral dose of the study drug SB-705498 on an oral capsaicin challenge in patients with chronic cough. The study drug SB-705498 selectively targets TRPV1 a ligand gated ion channel which is thought to be involved in causing chronic cough. This study will use an oral capsaicin challenge to determine the effect of the study drug. An oral capsaicin challenge is a proven method of inducing a cough in humans by using capasicin, an extract of hot pepper. The study will be carried out in two parts; Part A a phase I study of healthy subjects and Part B a phase IIa study in chronic cough patients. The dose of study drug to be administered in chronic cough patients (Part B) will be determined from the results of Part A which is a study in healthy subjects to determine the level of drug in the blood. Part A: Healthy subjects will receive a single 400mg (four 100mg tablets) dose of the study drug. Pharmacokinetic samples will be taken at regular intervals to analyse the bodies exposure to the study drug and consequently to determine the dose of the study drug to be administered in Part B. Part B: Subjects with chronic cough will complete 2 treatment periods during part B. Subjects will receive either:A) SB-705498 in treatment period 1 followed by placebo in treatment period 2OrB) Placebo in treatment period 1 followed by SB-705498 in treatment period 2Following administration of the study treatment in each treatment period subjects will undergo a oral capsaicin challenge in order to assess the effect of the treatment on the capsaicin cough threshold and its effect on 24 hour ambulatory cough counts (the number of coughs recorded during a 24 hour period).

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/H1008/2

• Date of REC Opinion

  1 Apr 2011

• REC opinion

  Further Information Favourable Opinion