Status:
COMPLETED
A Study to Investigate the Pharmacokinetics of Prolonged-release Melatonin Compared to Standard, Immediate-release Melatonin in Healthy Adults
Lead Sponsor:
Pharmavite LLC
Collaborating Sponsors:
KGK Science Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 un...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04067791
Start Date
August 1 2019
End Date
August 27 2019
Last Update
June 9 2020
Active Locations (1)
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1
KGK Science Inc.
London, Ontario, Canada, N6A 5R8