QCL-105018 (TC-6499-12-CLP-004)

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Proof of Principle Study to Evaluate the Safety, Tolerability, and Efficacy of TC-6499-12 in the Treatment of Constipation Predominant Irritable Bowel Syndrome.

• IRAS ID

  46340

• Contact name

  Stuart Mair

• Sponsor organisation

  Targacept Inc

• Eudract number

  2010-018902-35

• ISRCTN Number

  Unknown

• Research summary

  During in-vivo behavioural pharmacology tests in animals which addressed its pain killing properties, TC-6499 (as TC-6499-12) was associated with an increase in gastrointestinal motility marked by vomiting and/or diarrhoea. In three Phase I clinical studies, the vomiting and/or diarrhoea were considered adverse events and in one study using high doses caused the termination of the research. The primary purpose of this study is to specifically research the effectiveness of TC-6499-12 in treating constipation predominant irritable bowel syndrome. The secondary objectives are to evaluate the safety and tolerability of the IMP when used in this way and its pharmacokinetic profile. The study will be double-blind using active and placebo doses in the ratio 4:2 in each group

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  10/H0206/16

• Date of REC Opinion

  27 Apr 2010

• REC opinion

  Further Information Favourable Opinion