The effect of food content and insulin on QTc interval

• Research type

  Research Study

• Full title

  An open-label, randomised, placebo-controlled, crossover study to evaluate the effect of different foods, carbohydrate meal, and a euglycaemic insulin clamp on the QT/QTc interval of the ECG using a single 400 mg dose of moxifloxacin as a positive control in non-elderly healthy male and female, Caucasian and Japanese volunteers

• IRAS ID

  59093

• Sponsor organisation

  Richmond Pharmacology Ltd

• Eudract number

  2011-002423-17

• ISRCTN Number

  n/a

• Research summary

  Currently most Thorough QT (TQT) studies use 400 mg moxifloxacin as a positive control to confirm assay sensitivity as per ICH E14 guidelines. Food appears to also have an effect on the QT-RR relationship, increasing heart rate and shortening the corresponding QTc interval. Furthermore, food effect may be mediated by insulinaemia which prolongs QTc following food or by C-peptide which has been associated with QTc shortening. C-peptide is interesting as it may be responsible for the QTc shortening observed following a meal. The exact roles of insulin and C-Peptide on QTc interval following food under TQT conditions are not known. The possibility of proposing a food arm which is a simple, easy to standardise, and a non pharmacological alternative for the confirmation of TQT assay sensitivity will be investigated. This study has been designed and will be conducted at Richmond Pharmacology Limited (RPL).This study will involve up to 24 healthy males and females, Caucasian and Japanese subjects aged 20-45 years inclusive.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  11/LO/0764

• Date of REC Opinion

  29 Jun 2011

• REC opinion

  Further Information Favourable Opinion