Dose escAlation study of Melatonin in Sepsis: healthy voLunteers

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17088991

Enrollment

Registered

2012-04-24

Start date

2012-06-01

Completion date

Unknown

Last updated

2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis Infections and Infestations Sepsis, unspecified

Interventions

Oral melatonin, 20-100mg, single dose in cohorts of 5 subjects

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Male 2. Aged 18-30 years 3. <100kg 4. Not taking medication

Exclusion criteria

Exclusion criteria: 1. Female 2. 30 years 3. >100kg 4. Taking regular medication

Design outcomes

Primary

Measure	Time frame
Tolerance of the oral melatonin dose with no adverse events and approval by the Data Monitoring Committee to proceed to the next dose	—

Secondary

Measure	Time frame
Plasma levels and clearance of melatonin/metabolites at different doses measured at intervals up to 6 hours	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026