Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Melatonin in Healthy Female Volunteers

NCT03519750 | Completed Phase 1 DMC

• 1 other identifier: 2017-000997-13
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

We will investigate the safety and pharmacokinetics of melatonin, when administered rectally, intravesically, vaginally and transdermally. We will recruit 10 healthy female volunteers. The volunteers will have melatonin administered over 5 days; intravenously, rectally, intravesically, vaginally and transdermally. The participants will be followed for 24-48 hours with blood samples and questions about adverse events. There will be a wash-out between each session of a minimum of 7 days.

Conditions

Melatonin; Pharmacokinetics; Safety

Keywords

Melatonin; Safety; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• Plasma concentration of melatonin

  Plasma concentration of melatonin

  Baseline, 0 minutes, 10 minutes, 20 minutes, 30 minutes, 40 minutes, 50 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 24 hours

• Plasma concentration of melatonin

  Plasma concentration of melatonin

  Baseline, 0 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 24 hours, 48 hours

Secondary Outcomes (2)

• Karolinska Sleepiness Scale

  0 minutes, once hourly for 8 hours, and again at 24 hours

• Simple Reaction Time Test

  0 minutes, once hourly for 8 hours, and again at 24 hours

Study Arms (5)

Intravenous melatonin

ACTIVE COMPARATOR

Intravenous administration, making it possible to calculate bioavailability for other routes of administration

Drug: Melatonin 25 mg

Rectal melatonin

EXPERIMENTAL

Rectal administration of melatonin

Drug: Melatonin 25 mg

Intravesical melatonin

EXPERIMENTAL

Intravesical administration of melatonin

Drug: Melatonin 25 mg

Vaginal melatonin

EXPERIMENTAL

Vaginal administration of melatonin

Drug: Melatonin 25 mg

Transdermal melatonin

EXPERIMENTAL

Transdermal administration of melatonin

Drug: Melatonin 25 mg

Interventions

Melatonin 25 mg DRUG

24-48 hour monitoring of plasma melatonin as well as adverse events.

Intravenous melatonin; Intravesical melatonin; Rectal melatonin; Transdermal melatonin; Vaginal melatonin

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: They need to be female, in order to receive vaginal administration of melatonin
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy female
• years old
• BMI 18-30

You may not qualify if:

• Inability to understand Danish, written or spoken.
• Current use of melatonin or other hypnotics/sedatives
• Current pregnancy (a positive urine-HCG; the subjects will be tested prior to each study session)
• Breast feeding
• Current alcohol or drug abuse (defined as over 5 units of alcohol per day, or any usage of illegal drugs)
• Mental illness (defined as being in medical treatment)
• Serious comorbidity (American Society of Anesthesiologists (ASA) physical status 3-4)
• Participation in other clinical trials less than 1 month prior to current study
• Night-shift work within the last 14 days prior to study
• Planned night-shift work within the study period
• Known and diagnosed sleep-disorder (defined as being in current medical treatment)
• Plasma hemoglobin \<7.8 mmol/L (measured when screening participants)

Sponsors & Collaborators

• Dennis Bregner Zetner: lead
• Copenhagen University Hospital, Denmark: collaborator
• RepoCeuticals ApS: collaborator
• Herlev Hospital: collaborator

Study Sites (1)

Herlev Hospital

Herlev, 2000, Denmark

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Dennis B Zetner, MD

  Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Each volunteer will have melatonin administered through all five routes of administration, and will have a wash-out of a minimum of 7 days between each administration.

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 9, 2018
• Study Start: November 1, 2018
• Primary Completion: February 21, 2019
• Study Completion: February 21, 2019
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)