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HealthyPhase 1NCT04067791

A Study to Investigate the Pharmacokinetics of Prolonged-release Melatonin Compared to Standard, Immediate-release Melatonin in Healthy Adults

A Phase 1 study testing Prolonged-Release Melatonin and Immediate-Release Melatonin in people with Healthy, run by Pharmavite LLC at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Prolonged-Release Melatonin and Immediate-Release Melatonin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteCanada
Study dates
1 Aug 2019to 27 Aug 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • KGK Science Inc.

    London, Ontario, N6A 5R8

Other trials in Canada

About this study

Official title: 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.

Conditions
Healthy
Being tested
Prolonged-Release Melatonin, Immediate-Release Melatonin
Keywords
Healthy, Adult, Melatonin, Pharmacokinetic, Absorption, prolonged-release, immediate-release

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prolonged-Release MelatoninDietary supplement

    4.47 mg melatonin in a bi-layer prolonged-release capsule

  • Immediate-Release MelatoninDietary supplement

    4.47 mg melatonin in a standard release bi-layer capsule

Study groups in NCT04067791
Study groupRoleWhat they receive
Prolonged-Release melatonin then Immediate-release melatoninExperimentalNot described
Receives: Dietary Supplement: Prolonged-Release Melatonin; Dietary Supplement: Immediate-Release Melatonin
Immediate-Release Melatonin then Prolonged-Release MelatoninExperimentalNot described
Receives: Dietary Supplement: Prolonged-Release Melatonin; Dietary Supplement: Immediate-Release Melatonin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the area under the curve (AUC 0-10h)

    Measured: 7 days

  2. Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the time to peak concentration (tmax)

    Measured: 7 days

  3. Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the peak concentration (Cmax)

    Measured: 7 days

  4. Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the absorption rate constant

    Measured: 7 days

  5. Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the elimination rate constant

    Measured: 7 days

  6. Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the absorption half-life

    Measured: 7 days

  7. Comparison of the pharmacokinetics of prolonged-release melatonin and immediate-release melatonin by evaluating the elimination half-life

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2019
  2. Study start1 Aug 2019
  3. Primary completion27 Aug 2019
  4. Study completion27 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04067791
Sponsor's protocol ID
19MPHP
Status last verified
Jun 2020
First submitted
19 Aug 2019
Last updated
9 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mun JG, Wang D, Doerflein Fulk DL, Fakhary M, Gualco SJ, Grant RW, Mitmesser SH. A Randomized, Double-Blind, Crossover Study to Investigate the Pharmacokinetics of Extended-Release Melatonin Compared to Immediate-Release Melatonin in Healthy Adults. J Diet Suppl. 2024;21(2):182-194. doi: 10.1080/19390211.2023.2206475. Epub 2023 May 7.

    PubMed 37150895

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Prolonged-Release Melatonin and Immediate-Release Melatonin in people with Healthy, run by Pharmavite LLC at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04067791, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.

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