Clinical trial NCT03519750: Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Melatonin in Healthy Female Volunteers
Official title: Pharmacokinetics of Intravenous, Rectal, Intravesical, Vaginal, and Transdermal Administration of Exogenous Melatonin in Healthy Female Volunteers: a Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melatonin
Pharmacokinetics
Safety
Keywords: Melatonin
Safety
Pharmacokinetics
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Denmark
name: RepoCeuticals ApS
name: Herlev Hospital
First posted: 2018-05-09
Enrollment: 10
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Plasma concentration of melatonin
timeFrame: 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
measure: Plasma concentration of melatonin
timeFrame: 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:
measure: Karolinska Sleepiness Scale
timeFrame: 0 minutes, once hourly for 8 hours, and again at 24 hours
measure: Simple Reaction Time Test
timeFrame: 0 minutes, once hourly for 8 hours, and again at 24 hours
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Center for Perioperative Optimization, Department of Surgery, Herlev Hospital, Denmark
name: Dennis B Zetner, MD
role: PRINCIPAL_INVESTIGATOR
References: