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

Phase 1CompletedNCT03519750

Dennis Bregner Zetner10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Melatonin Pharmacokinetics Safety

Interventions

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Plasma concentration of melatonin

Time frame: 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

Time frame: 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

Karolinska Sleepiness Scale

Scale which evaluates tiredness of participants

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

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.