Can MK-7622 reverse the sedative effects of hyoscine? (version 1)

• Research type

  Research Study

• Full title

  A study to evaluate the reversal of cognitive impairment in healthy subjects by MK-7622 (HMR 10-014)

• IRAS ID

  60545

• Contact name

  Steve Warrington

• Sponsor organisation

  Merck Sharp & Dohme Corp

• Eudract number

  2010-020901-33

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study medicine is an experimental treatment of Alzheimer's disease.It has already been tested in healthy young men.We-re doing this study to find out if the study medicine improves brain function.To do that, We'll give Participants hyoscine, which is often used to treat travel-sickness and for preparing patientsfor operations.At the dose We'll use, hyoscine has sedative effects - it briefly impairs memory, attention, and problem solving.We'll test to see if the study medicine reverses the sedative effects of hyoscine.We'll compare the study medicine with donepezil - a medicine that is already used to treat Alzheimer's disease, and is known to reverse the effects of hyoscine.The study will be in 2 parts.In Part 1 We'll test whether the study medicine alone and donepezil alone reverse the effects of hyoscine.In Part 2 We'll test whether the study medicine in combination with donepezil reverses the effects of hyoscine.We also find out the side effects and blood levels of the study medicine, hyoscine and donepezil; and study how genes (pieces of DNA) affect the way the body responds to or handles the study medicine. they'll be up to 54 healthy men in the study, aged 18-45 years.Participants in Part 1 will take up to 14 weeks to finish the study.they'll stay on the ward for 10 nights in total, and make 2 outpatient visits.Participants in Part 2 will take up to 8 weeks to finish the study.they'll stay on the ward for 4 nights in total, and make 2 outpatient visits.A pharmaceutical company is funding the study, which will take place at 1 centre in London.We'll recruit healthy Participants by:advertising in newspapers and on websites; by word of mouth; and from our volunteer database.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/19

• Date of REC Opinion

  1 Sep 2010

• REC opinion

  Further Information Favourable Opinion