Clinical trial NCT04910061: Safety and Pharmacokinetics of Nicotinamide Mononucleotide (NMN) in Healthy Adults.
Official title: A Single-centre Trial to Investigate the Safety and Pharmacokinetics of Orally Administered Nicotinamide Mononucleotide (NMN, 400mg) Over 29 Days of Supplementation in Healthy Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: safety
pharmacokinetics
Lead sponsor: Seneque SA
Sponsor class: INDUSTRY
Collaborators: name: Dicentra Inc.
name: LGD
First posted: 2021-06-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm, non-randomized, non-controlled, monocenter repeated-dose study
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the safety, pharmacokinetic profile, and effects of nicotinamide mononucleotide (NMN-C) in healthy adults, 18-65 years of age. The effects will be studied over the course of 30 days in a repeated-dose study through the collection of blood and urine samples, and administration of surveys and questionnaires.


Eligibility criteria: Inclusion Criteria:

* Naturally post-menopausal women with amenorrhea for 1 year will be eligible.
* Females of childbearing potential should be either sexually inactive (abstinent) for 60 days prior to the first dose of the study, throughout the study and for 30 days after completion of the study, or be using an acceptable methods of birth control.
* BMI between 18.5 and 29.9 kg/m2; with a stable weight over the last 3 months (±2 kg).
* Having given written informed consent to participate in the research trial.
* Agrees to maintain current dietary habits and level of physical activity for the trial duration, except as directed by the Nutritionist Agrees to follow dietary guidelines, consume standardized meals, and abide by dietary guidelines for dinner prior to specified visits (as outlined by Nutritionist at screening)

Exclusion Criteria:

* Known or suspected allergy to any of the ingredients in the investigational product or standardized meals.
* Active infection, or history of infection and/or antibiotic use 2 weeks prior to the screening visit as assessed by Investigator.
* Presenting, in the opinion of the Investigator, a clinically significant abnormality with regard to the clinical examination and/or clinical chemistry screening parameters.
* Have a history of, or present with, cardiovascular, renal, hepatic, endocrine, gastrointestinal, or inflammatory disease, as assessed by Investigator.
* Has consumed multivitamins or supplements (such as St. John's Wort) within 1 month prior to the study, or unwilling to discontinue use for the duration of the study
* History of cancer in the last 5 years, or currently has cancer, as assessed by Investigator.
* Has a history of, or current neurological (neurodegenerative diseases, epilepsy) or psychiatric pathology that may impact the participant's ability to comply with the requirements of the protocol, as assessed by Investigator.
* Presenting with immune suppression (e.g. autoimmune disease, HIV), as assessed by Investigator.
* Has undergone surgery in the last 3 months, or has surgery planned during the trial period, as assessed by Investigator.
* Uses concomitant medications including natural health products (excluding contraceptives and PRN or other medications, which in the Investigator's opinion, do not affect the trial outcomes or participant safety).
* Currently following a regimented or restricted diet which in the opinion of the Nutritionist and/or PI would negatively affect the study outcome or participants' ability to comply with study requirements, or has in the 3 months prior to enrollment.
* Plans to change dietary habits and/or activity level during the trial period.
* Frequent consumption of alcohol (\> 2 standard servings of alcohol/day on average).
* History of (assessed by PI) or current tobacco use (verified by positive cotinine urinalysis)
* Positive urinalysis for drugs of abuse (amphetamines, Cannabinoids, Cocaine and Opiates)
* Presenting a niacin deficiency, as assessed by Nutritionist's dietary assessment at screening, and Investigator's physical examination.
* Has difficulty swallowing capsules.
* Inability to provide blood and/or urine samples.
* Positive pregnancy test, intent to get pregnant, or breastfeeding.
* Any other condition that, in the opinion of the Investigator, could impair the Investigator's ability to complete the study outcomes and participant safety. Participating simultaneously in another clinical research protocol or having participated in another research study for which the exclusion period would not be completed

Primary outcomes:
measure: Safety as measured by subject incident of treatment-emergent adverse events
timeFrame: between Day 1 and Day 30
measure: Safety as measured by subject incident of treatment-emergent clinically significant changes in vital signs
timeFrame: between Day 1 and Day 30
measure: Safety as measured by subject incident of treatment-emergent clinically significant changes in clinical laboratory safety tests.
timeFrame: between Day 1 and Day 30
Secondary outcomes:
measure: Change from baseline in NAD+ and NMN concentrations in whole blood
timeFrame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
measure: Change from baseline in NAD+ and NMN concentrations in whole blood
timeFrame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
measure: Change from baseline in NAD+ metabolites concentrations in plasma
timeFrame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
measure: Change from baseline in NAD+ metabolites concentrations in plasma
timeFrame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
measure: Change from baseline in NAD+ metabolites concentrations in urine
timeFrame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
measure: Change from baseline in NAD+ metabolites concentrations in urine
timeFrame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
measure: Change from baseline in NAD+ and NMN concentrations in whole blood
timeFrame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
measure: Change from baseline in NAD+ metabolites concentrations in plasma
timeFrame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
measure: Change from baseline in NAD+ metabolites concentrations in urine
timeFrame: Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
measure: Changes in body weight
timeFrame: Day 1, Day 29
measure: Tolerance
timeFrame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
measure: Changes in Quality of life
timeFrame: Day 1, Day 29
measure: Changes in Sleep quality
timeFrame: Day 1, Day 29
measure: Changes in Fatigue state
timeFrame: Day 1, Day 29
measure: Change in blood lipid profile from baseline during the intervention period
timeFrame: Day 1, Day 29
measure: Change in blood glucose (fasting) from baseline during the intervention period
timeFrame: Day 1, Day 29
measure: Change from baseline in homocysteine concentrations
timeFrame: Day 1, Day 29
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Vitalabs Clinic
state: Ontario
Study officials:
References: