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More info
You can access this
clinical trial
if you have
Sepsis
and you are
between 18 and 30
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

Antioxidant therapy targeted at mitochondria has the potential to reduce inflammation, mitochondrial damage and organ dysfunction in sepsis. Melatonin accumulates in mitochondria and both it and its metabolites have potent antioxidant and anti-inflammatory activity, preventing organ dysfunction in a rat model of sepsis. The investigators propose a study in healthy volunteers to assess the tolerability and pharmacokinetics of exogenous melatonin and its major metabolites and to relate these doses to ex vivo anti-inflammatory and antioxidant activities. Groups of healthy subjects will receive increasing sequential doses of oral melatonin in an open label dose escalation study. Ex vivo inflammatory responses, oxidative stress and mitochondrial function at concentrations of melatonin identified in the dose escalation study will be determined following exposure of whole blood to an inflammatory insult. This will provide crucial information to inform a subsequent phase II clinical trial of melatonin in patients with sepsis.

Provided treatments

  • Drug: Melatonin
  • Drug: Melatonin
  • Drug: Melatonin
  • Drug: Melatonin

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01724424. The sponsor of the trial is University of Aberdeen and it is looking for 20 volunteers for the current phase.
Official trial title:
A Dose Escalation Study of Melatonin in Healthy Volunteers as a Potential Treatment for Sepsis