Melatonin in Healthy Volunteers

NCT01724424 | Completed Phase 1 DMC

• 1 other identifier: 3/057/11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Number of participants in each dose group with adverse events

  Adverse events : nausea, vomiting, diarrhoea, itching, headache, drowsiness and any other symptoms for 6h immediately after dosing and again after 1 week. Sleeping patterns will also be assessed after 1 week. Altered heart rate, oxygen saturation, ECG, blood pressure. Changes in biochemistry (sodium , potassium, urea, AST, creatinine, glucose) or haematology (WBC and differential counts). All events will be graded according to prospectively defined criteria.

  6h and 1 week

Study Arms (4)

melatonin 20mg

EXPERIMENTAL

2 x 10mg capsules of melatonin, single dose. Blood sampling and physiological measures (blood pressure, ECG, oxygen saturation) every 30 mins for 6 hours.

Drug: Melatonin

melatonin 30mg

EXPERIMENTAL

3 x 10mg capsules of melatonin, single dose. Blood sampling and physiological measures (blood pressure, ECG, oxygen saturation) every 30 mins for 6 hours.

Drug: Melatonin

Melatonin 50mg

EXPERIMENTAL

5 x 10mg capsules of melatonin, single dose. Blood sampling and physiological measures (blood pressure, ECG, oxygen saturation) every 30 mins for 6 hours.

Drug: Melatonin

Melatonin 100mg

EXPERIMENTAL

10 x 10mg capsules of melatonin, single dose. Blood sampling and physiological measures (blood pressure, ECG, oxygen saturation) every 30 mins for 6 hours.

Drug: Melatonin

Interventions

Melatonin DRUG

20 mg oral single dose

Also known as: N-acetyl-5-methoxytryptamine

melatonin 20mg

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• male
• aged 18-30 years
• less than 100kg body weight
• non-smoker
• no regular medication

You may not qualify if:

• female
• over 100kg
• under 18 years
• over 30 years

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

University of Aberdeen

Aberdeen, Scoltand, AB25 2ZD, United Kingdom

Location

MeSH Terms

Conditions

Sepsis

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Nigel Webster

  University of Aberdeen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: November 9, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

GB (1)