Evaluate the Effects of Single Doses of MK-3697 on Polysomnography

• Research type

  Research Study

• Full title

  A crossover study to evaluate the effects of single doses of MK-3697 and MK-6096 on Polysomnography (PSG) measurements in subjects.

• IRAS ID

  60932

• Contact name

  Maria Kasti

• Sponsor organisation

  Merck Sharp & Dohme

• Eudract number

  2010-021288-34

• Research summary

  MK-3697 and MK-6096 are drugs that may be useful in the treatment of insomnia (persistent difficulty in falling asleep or staying asleep). They work by blocking the effects of a group of chemicals called Orexins. These chemicals are thought to play an important part in regulating the sleep/wake cycle in man. The purpose of this study is to examine the effects of MK-3697 and MK-6096 on the nature of sleep and its tolerability in various single oral (by mouth) doses, when given to healthy young volunteers.Twenty (20) healthy male subjects will be enrolled into the study, which will be approximately 12 weeks in duration. Subjects will participate in 5 treatment periods, each involving an admission to the Unit. For treatment periods 1-5, each admission lasts for 4 days (3 nights).

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/62

• Date of REC Opinion

  17 Sep 2010

• REC opinion

  Further Information Favourable Opinion