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

Pharmacokinetics Clinical Trial

Official title:

Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Administration of Exogenous Melatonin in Healthy Female Volunteers: a Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519750
• Other study ID #: 2017-000997-13
• Status: Completed
• Phase: Phase 1
• Start date: November 1, 2018
• Est. completion date: February 21, 2019

Study information

• Verified date: April 2019
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 21, 2019
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion criteria:

• Healthy female

• 20-40 years old

• BMI 18-30

Exclusion criteria:

• 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)

Related Conditions & MeSH terms

• Melatonin
• Pharmacokinetics
• Safety

Intervention

Drug:
• Melatonin 25 mg
24-48 hour monitoring of plasma melatonin as well as adverse events.

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (4)

Lead Sponsor	Collaborator
Dennis Bregner Zetner	Copenhagen University Hospital, Denmark, Herlev Hospital, RepoCeuticals ApS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Karolinska Sleepiness Scale	Scale which evaluates tiredness of participants	0 minutes, once hourly for 8 hours, and again at 24 hours
Secondary	Simple Reaction Time Test	A simple reaction time test which measures the participants' reaction time; they are looking at a red lamp, and need to react when it changes to green.	0 minutes, once hourly for 8 hours, and again at 24 hours