- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04067791
A Study to Investigate the Pharmacokinetics of Prolonged-release Melatonin Compared to Standard, Immediate-release Melatonin in Healthy Adults
June 8, 2020 updated by: Pharmavite LLC
A Randomized, Double-blind, Comparator-controlled, Cross-over Study to Investigate the Pharmacokinetics of Prolonged-release Melatonin Compared to Standard, Immediate-release Melatonin in Healthy Adults
A study comparing the pharmacokinetics of prolonged-release melatonin versus standard, immediate-release melatonin.
Multiple blood draws over a 10-hour period will be analysed to determine the area under the curve, time to peak concentration, peak concentration, absorption rate constant, elimination rate constant, absorption half-life, and elimination half-life.
Vital signs, hematology parameters, clinical chemistry parameters, and incidence of adverse events are also analysed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5R8
- KGK Science Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Females and males between 18 and 65 years of age at screening
- BMI between 18.5 to 29.9 kg/m2, inclusive
- Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening Or, Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. Acceptable methods of birth control include: e. Non-hormonal intrauterine devices f. Double-barrier method g. Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) h. Vasectomy of partner at least 6 months prior to screening
- Male participants must agree to the use of condoms unless partner is using an acceptable form of female contraception as defined in Inclusion #3 or a form of hormonal birth control during the study treatment period and for at least 7 days after completion of the study
- Have a regular sleep-wake cycle with a bedtime between 9:00 pm and 12:00 am and receive between 7 and 8 hours of sleep for at least 3 weeks
- Agrees to maintain current sleep schedule throughout study
- Agrees to maintain current level of physical activity and diet throughout the study
- Agrees to comply with all study procedures
- Agrees to consume standardized meals during Visits 2 and 3
- Agrees to avoid caffeine intake 24 hours prior to Visits 2 and 3
- Agrees to avoid alcohol intake 24 hours prior to Visits 2 and 3
- Healthy as determined by medical history, laboratory results, and physical exam as assessed by QI
- Agrees to provide informed written consent
Exclusion Criteria:
- Women who are pregnant, breastfeeding or planning to become pregnant during the course of the trial
- Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients, or the ingredients in the standardized meals
- Current use of hormonal contraceptives
- Previous diagnosis of a sleep disorder or use of continuous positive air pressure (C-PAP)
- Registered with the Canadian National Institute for the Blind (CNIB) and considered as legally blind
- Current employment that calls for rotating shift work or shift work that will disrupt normal circadian rhythm or have worked shift work in the last 3 weeks
- Travel across 1 or more time zones in the last 2 weeks and/or is anticipating more travel
- Currently experiencing vivid nightmares or sleepwalking
- Diagnosis of any pineal gland abnormalities or have undergone pinealectomy
- Current or history of any significant diseases of the gastrointestinal tract
- Unstable metabolic disease or chronic diseases as assessed by the QI
- Verbal confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Type I or Type II diabetes
- Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than 5 years after diagnosis are acceptable
- Individuals with an autoimmune disease or are immune-compromised
- Verbal confirmation of medical or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
- Verbal confirmation of an HIV-, Hepatitis B- and/or C-positive diagnosis
- History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones symptom-free for 6 months
- Major surgery in the past 3 months or individuals who have planned surgery, that may impact the outcomes of the study, during the course of the trial. Participants will be considered on a case-by-case basis by the QI
- Blood/bleeding disorders as determined by laboratory results
- An acute gout attack within the past 3 months
- Current use of prescribed medications listed in the con meds section
- Current use of over-the-counter medications, supplements, foods and/or drinks listed in the con meds section
- Use of medical marijuana
- Use of recreational marijuana unless willing to undergo 1-month washout
- Use of tobacco products within 1-year of baseline
- Alcohol or drug abuse within the last 12 months
- High alcohol intake (average of >2 standard drinks per day or >10 standard drinks per week)
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Blood donation within the past 6 months will be assessed on a case by case basis by the QI depending on volume and frequency of donation, and laboratory parameters
- Plans to donate blood during the study or within 56 days for males and 84 days for females, the last study visit
- Participation in other clinical research trials 30 days prior to randomization
- Individuals who are unable to give informed consent
- Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prolonged-Release melatonin then Immediate-release melatonin
|
4.47 mg melatonin in a bi-layer prolonged-release capsule
4.47 mg melatonin in a standard release bi-layer capsule
|
Experimental: Immediate-Release Melatonin then Prolonged-Release Melatonin
|
4.47 mg melatonin in a bi-layer prolonged-release capsule
4.47 mg melatonin in a standard release bi-layer capsule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the area under the curve (AUC 0-10h)
Time Frame: 7 days
|
7 days
|
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the time to peak concentration (tmax)
Time Frame: 7 days
|
7 days
|
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the peak concentration (Cmax)
Time Frame: 7 days
|
7 days
|
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the absorption rate constant
Time Frame: 7 days
|
7 days
|
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the elimination rate constant
Time Frame: 7 days
|
7 days
|
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the absorption half-life
Time Frame: 7 days
|
7 days
|
Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the elimination half-life
Time Frame: 7 days
|
7 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood pressure after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in heart rate after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in weight after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in body mass index (BMI) after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in Red Blood Cell (RBC) count after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in Mean Corpuscular Volume (MCV) after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in Mean Corpuscular Hemoglobin (MCH) after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in Hematocrit after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in Red Cell Distribution Width (RDW) after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in Hemoglobin (Hb) after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in neutrophils after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in lymphocytes after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in monocytes after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in eosinophils after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in basophils after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in alanine aminotransferase (ALT) after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in aspartate aminotransferase (AST) after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in creatinine after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in electrolytes after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
Na+, K+, and Cl- will be assessed
|
7 days
|
Change in estimated glomerular filtration rate (eGFR) after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in total bilirubin after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
|
Change in adverse events after an acute administration of either prolonged-release melatonin or immediate-release melatonin
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2019
Primary Completion (Actual)
August 27, 2019
Study Completion (Actual)
August 27, 2019
Study Registration Dates
First Submitted
August 19, 2019
First Submitted That Met QC Criteria
August 22, 2019
First Posted (Actual)
August 26, 2019
Study Record Updates
Last Update Posted (Actual)
June 9, 2020
Last Update Submitted That Met QC Criteria
June 8, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19MPHP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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