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

NCT04067791 | Completed Phase 1

• 1 other identifier: 19MPHP
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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, absorption half-life, and elimination half-life. Vital signs, hematology parameters, clinical chemistry parameters, and incidence of adverse events are also analysed.

Conditions

Healthy

Keywords

Healthy; Adult; Melatonin; Pharmacokinetic; Absorption; prolonged-release; immediate-release

Outcome Measures

Primary Outcomes (7)

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

  7 days

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

  7 days

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

  7 days

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

  7 days

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

  7 days

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

  7 days

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

  7 days

Other Outcomes (23)

• Change in blood pressure after an acute administration of either prolonged-release melatonin or immediate-release melatonin

  7 days

• Change in heart rate after an acute administration of either prolonged-release melatonin or immediate-release melatonin

  7 days

• Change in weight after an acute administration of either prolonged-release melatonin or immediate-release melatonin

  7 days

Study Arms (2)

Prolonged-Release melatonin then Immediate-release melatonin

EXPERIMENTAL

Dietary Supplement: Prolonged-Release Melatonin; Dietary Supplement: Immediate-Release Melatonin

Immediate-Release Melatonin then Prolonged-Release Melatonin

EXPERIMENTAL

Dietary Supplement: Prolonged-Release Melatonin; Dietary Supplement: Immediate-Release Melatonin

Interventions

Prolonged-Release Melatonin DIETARY_SUPPLEMENT

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

Immediate-Release Melatonin then Prolonged-Release Melatonin; Prolonged-Release melatonin then Immediate-release melatonin

Immediate-Release Melatonin DIETARY_SUPPLEMENT

4.47 mg melatonin in a standard release bi-layer capsule

Immediate-Release Melatonin then Prolonged-Release Melatonin; Prolonged-Release melatonin then Immediate-release melatonin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmavite LLC: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6A 5R8, Canada

Location

Related Publications (1)

• 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.

  PMID: 37150895 DERIVED

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 26, 2019
• Study Start: August 1, 2019
• Primary Completion: August 27, 2019
• Study Completion: August 27, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)