Safety and Pharmacokinetics of Nicotinamide Mononucleotide (NMN) in Healthy Adults.

NCT04910061 | Completed

• 1 other identifier: 20-NNHSP-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

safety; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Safety as measured by subject incident of treatment-emergent adverse events

  Subject incidence of treatment-emergent adverse events

  between Day 1 and Day 30

• Safety as measured by subject incident of treatment-emergent clinically significant changes in vital signs

  Subject incidence of treatment-emergent clinically significant changes in vital signs (body temperature, heart rate and blood pressure)

  between Day 1 and Day 30

• Safety as measured by subject incident of treatment-emergent clinically significant changes in clinical laboratory safety tests.

  Subject incidence of treatment-emergent clinically significant changes in clinical laboratory safety tests (Complete blood count, C reactive protein, AST, ALT, bilirubin, GGT, Alkaline phosphatase, creatinine, creatine kinase, Sodium, Potassium, Chloride)

  between Day 1 and Day 30

Secondary Outcomes (17)

• Change from baseline in NAD+ and NMN concentrations in whole blood

  Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1

• Change from baseline in NAD+ and NMN concentrations in whole blood

  Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30

• Change from baseline in NAD+ metabolites concentrations in plasma

  Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1

• Change from baseline in NAD+ metabolites concentrations in plasma

  Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30

• Change from baseline in NAD+ metabolites concentrations in urine

  Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1

Study Arms (1)

NMN-C

EXPERIMENTAL

Healthy individuals receiving NMN-C

Dietary Supplement: Nicotinamide mononucleotide (NMN-C)

Interventions

Nicotinamide mononucleotide (NMN-C) DIETARY_SUPPLEMENT

Daily supplementation with NMN-C at 400 mg for 29 days in total

NMN-C

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seneque SA: lead
• Dicentra Inc.: collaborator
• LGD: collaborator

Study Sites (1)

Vitalabs Clinic

Toronto, Ontario, M5S 2B7, Canada

Location

MeSH Terms

Interventions

Nicotinamide Mononucleotide

Intervention Hierarchy (Ancestors)

Ribonucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single-arm, non-randomized, non-controlled, monocenter repeated-dose study

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: June 2, 2021
• Study Start: August 5, 2021
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)