Melatonin in healthy volunteers

• Research type

  Research Study

• Full title

  A dose escalation study of melatonin in healthy volunteers as a potential treatment for sepsis

• IRAS ID

  102537

• Contact name

  Nigel Webster

• Sponsor organisation

  Norfolk and Norwich NHS Foundation Trust

• Eudract number

  2012-001185-15

• Research summary

  Sepsis is a severe infection and has a very high mortality rate. Most of the patients who die do so as a result of organ failure. We have shown in laboratory studies that melatonin has properties which protect against the development of organ failure. This proposal is a study in healthy volunteers to assess the tolerability and pharmacokinetics of various doses of melatonin to relate these doses to what we see in the laboratory. Groups of healthy men will receive oral melatonin in an open label dose escalation study. This will provide crucial information to inform a subsequent phase II clinical trial of melatonin in patients with sepsis.

• REC name

  Scotland A REC

• REC reference

  12/SS/0057

• Date of REC Opinion

  4 May 2012

• REC opinion

  Further Information Favourable Opinion