A study investigating 6 formulations of Lu AF11167 in HVs (QBR115050)

• Research type

  Research Study

• Full title

  Interventional, open-label, part fixed sequence, part-randomised study investigating the pharmacokinetic properties of up to 6 prototype modified release tablet formulations of Lu AF11167 in healthy young subjects

• IRAS ID

  158998

• Contact name

• Sponsor organisation

  H. Lundbeck A/S

• Eudract number

  2013-004887-77

• Clinicaltrials.gov Identifier

  NCT02260830

• Research summary

  The Sponsor, Lundbeck, is developing the study medicine Lu AF11167 for the potential treatment of symptoms of schizophrenia. The studies conducted with Lu AF11167 so far have not given rise to safety concerns. However, Lu AF11167 has been found to cause side effects, mainly sleepiness / drowsiness and also related to muscles such as involuntary muscle contractions, spasms and tremor at high doses. The side effects are dose-dependent and their severity limits how much medicine a subject can tolerate. The aim of this study is to slow down the speed at which the body takes up Lu AF11167, and thereby reduce the highest concentration of medicine in the body.
  The study will investigate this by giving up to 6 new different tablets by mouth, each of which dissolves more slowly than the current tablet in clinical development. One tablet will be chosen for further investigation, and the effect of taking this tablet with and without food, and taking the tablet multiple times will be studied.
  The study will consist of 2 parts. Part A will include 16 young healthy volunteers (male and female). Each volunteer will receive one tablet by mouth of the reference tablet on one occasion, followed by one tablet of up to 5 modified release tablets on separate occasions. Part B will include 12 young healthy volunteers who will each receive a tablet based on the results from Part A of the study. This chosen tablet will be investigated on an empty stomach and following a high fat meal, and following multiple tablets. Blood samples will be taken at various timepoints to follow the levels of the drug in the body. The study duration is 73 days and 30 days respectively for Parts A and Part B.

• REC name

  Wales REC 1

• REC reference

  14/WA/1020

• Date of REC Opinion

  11 Jul 2014

• REC opinion

  Further Information Favourable Opinion