Drug-Drug Interaction Study with ulimorelin & midazolam

• Research type

  Research Study

• Full title

  An open-label, single centre, randomised, cross-over study to examine the effect of ulimorelin on the pharmacokinetics of midazolam after repeat dose administration of ulimorelin in healthy volunteers.

• IRAS ID

  79690

• Contact name

  David Bell

• Sponsor organisation

  Norgine Ltd

• Eudract number

  2011-001273-54

• Research summary

  This study will examine the interaction between a drug being developed for the treatment of post-operative ileus and gastroparesis and midazolam. The purpose of this study is to provide information on how the drug being developed affects a group of proteins in the liver known as CYP3A4. These proteins are important as they are responsible for the metabolism of various other medicines. By examining how the drug interacts with midazolam (recommended in EMA guidelines as being the drug of choice for examining effects with CYP 3A4) we will be able to determine if the drug under development has the potential to interact with other medications.The duration of the study will be 26 days (excluding the screening period). The drug will be administered as a daily intravenous infusion over 30 minutes on Days 1 to 5 during treatment B. Midazolam will be administered orally as a single dose on Day 1 (treatment A) or Day 5 (treatment B).Fourteen healthy volunteers aged between 18 and 45 will be randomised.

• REC name

  HSC REC B

• REC reference

  11/NI/0068

• Date of REC Opinion

  23 May 2011

• REC opinion

  Favourable Opinion