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A Novel Inhaled Formulation of Melatonin to Treat Adults With Insomnia: Pharmacokinetic Study

NCT06801379 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-07-18

No results posted yet for this study

Summary

The goal of this clinical trial is to explore the potential benefits of an inhaled version of melatonin compared to oral melatonin tablets on adults with insomnia. The main question the trial aims to answer: is the time required for inhaled melatonin to reach peak concentration in the blood and then be eliminated from body different to that of oral melatonin tablets, in adults with insomnia?

5 participants will:

* Visit the research institute for a screening visit and for a daytime visit to take a melatonin treatment then provide blood samples over the course of 8 hours for each study drug treatment (3 visits in total)
* Take 100 μg of inhaled melatonin (2 inhaler puffs) once
* Take a 4 mg of oral melatonin (2 tablets) once

Conditions

Interventions

DRUG

Inhaled Melatonin (100 μg)

An orally inhaled formulation of melatonin delivered by pressurised metered dose inhaler (pMDI) to be taken before bedtime. The pMDI will deliver a total of 100 μg of inhaled melatonin (2 x 50 μg/actuation). The investigational product is produced under Good Manufacturing Practice by Ab Initio Pharma Pty Ltd, a GMP certified manufacturer of pharmaceutical products.

DRUG

Oral Melatonin (4 mg)

Two orally ingested tablets each containing 2 mg of melatonin (4 mg total) to be taken before bedtime. The investigational product is manufactured under Good Manufacturing Practice and is compliant with the TGA Therapeutic Order #101 that stipulates quality control requirements for capsule and pill-based products used in Australia.

Sponsors & Collaborators

  • Woolcock Institute of Medical Research

    lead OTHER

Principal Investigators

  • Hui Xin Ong, PhD · Woolcock Institute of Medical Research

  • Ron Grunstein, MBBS MD PhD FRACP · Woolcock Institute of Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-12-31
Completion
2026-05-01

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06801379 on ClinicalTrials.gov