Safety and blood levels of MK-6096 in older people; version 1

• Research type

  Research Study

• Full title

  A single dose study to evaluate the safety, tolerability, and pharmacokinetics of MK-6096 in elderly subjects (HMR code 09-004)

• IRAS ID

  22559

• Contact name

  Steve Warrington

• Eudract number

  2009-011677-32

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study medicine is an experimental medicine for insomnia (inability to fall asleep or stay asleep). The study medicine blocks orexin receptors, which are sites in the brain that seem to be involved in our daily cycle of sleeping and waking. We expect that, by blocking those sites, the study medicine will help people to fall asleep and stay asleep. We plan to do this study in healthy elderly volunteers, because disturbed sleep is common in older people.We aim to find out the side effects and blood levels of the study medicine, and test whether it makes older people feel sleepy or affects their mood.We'll give a single dose of 20 mg study medicine to 20 healthy elderly men and women, aged 60-85 years. Some participants will take dummy medicine instead of the study medicine - neither they nor we will know which one they??re taking.Participants will take up to 6 weeks to finish the study. They'll make 2 outpatient visits, and stay on the ward for 3 days and nights.A pharmaceutical company is funding the study. The study will take place at 1 site in London. We'll recruit healthy participants: by advertising (newspaper, radio and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  09/H0717/29

• Date of REC Opinion

  26 May 2009

• REC opinion

  Favourable Opinion