Trial · Interventional
CompletedNot applicableRegistry dataSafety and Pharmacokinetics of Nicotinamide Mononucleotide (NMN) in Healthy Adults.
Overview
- Status
- Completed
- Phase
- Not applicable
- Enrollment
- 24 participants (actual)
- Sponsor
- Seneque SA · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
Canada
- Start
- 5 Aug 2021
- Primary completion
- 1 Sept 2022
- Completion
- 1 Mar 2023
- First posted
- 2 Jun 2021
- Last update posted
- 30 Mar 2023
- Conditions
- Healthy Volunteers
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- N/A
Safety and Pharmacokinetics of Nicotinamide Mononucleotide (NMN) in Healthy Adults.
NCT049100615 Aug 2021 to 1 Mar 2023
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Nicotinamide mononucleotide (NMN-C)Dietary supplement
Arms1
Experimental
NMN-C
Healthy individuals receiving NMN-C
Primary outcomes3
Outcomes the sponsor listed as primary.
Safety as measured by subject incident of treatment-emergent adverse events
Time frame · between Day 1 and Day 30
Registry description
Subject incidence of treatment-emergent adverse events
Safety as measured by subject incident of treatment-emergent clinically significant changes in vital signs
Time frame · between Day 1 and Day 30
Registry description
Subject incidence of treatment-emergent clinically significant changes in vital signs (body temperature, heart rate and blood pressure)
Safety as measured by subject incident of treatment-emergent clinically significant changes in clinical laboratory safety tests.
Time frame · between Day 1 and Day 30
Registry description
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)
Secondary outcomes(17)
Change from baseline in NAD+ and NMN concentrations in whole blood
Time frame · Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
Registry description
NAD+ and NMN will be assessed in blood at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Change from baseline in NAD+ and NMN concentrations in whole blood
Time frame · Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Registry description
NAD+ and NMN will be assessed in blood
Change from baseline in NAD+ metabolites concentrations in plasma
Time frame · Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
Registry description
MeNAM and NAM will be assessed in plasma at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Change from baseline in NAD+ metabolites concentrations in plasma
Time frame · Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Registry description
MeNAM and NAM will be assessed in plasma
Change from baseline in NAD+ metabolites concentrations in urine
Time frame · Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1
Registry description
MeNAM and Me-2-PY will be assessed in urine at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Change from baseline in NAD+ metabolites concentrations in urine
Time frame · Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Registry description
MeNAM and Me-2-PY will be assessed in urine
Change from baseline in NAD+ and NMN concentrations in whole blood
Time frame · Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
Registry description
NAD+ and NMN will be assessed in blood at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Change from baseline in NAD+ metabolites concentrations in plasma
Time frame · Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
Registry description
MeNAM and NAM will be assessed in plasma at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Change from baseline in NAD+ metabolites concentrations in urine
Time frame · Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29
Registry description
MeNAM and Me-2-PY will be assessed in urine at the following time points : t=0 hours (pre-dose), t=0.25 hours, t=0.5 hours, t=1 hours, t=2 hours, t=4 hours, t=8 hours and t=12 hours after dosing
Changes in body weight
Time frame · Day 1, Day 29
Tolerance
Time frame · Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30
Registry description
The number of participants with Adverse Events
Changes in Quality of life
Time frame · Day 1, Day 29
Registry description
the mean changes in the the generic Quality of Life Self-Assessment Questionnaire SF-36 questionnaire score (The SF-36 questionnaire is scaled from a 0 to 100. The lower the score the more disability)
Changes in Sleep quality
Time frame · Day 1, Day 29
Registry description
the mean changes in the Sleep Quality Scale (SQS) score (SQS is providing an overall score ranging from 0 to 84, where lower scores denote a healthier sleep quality)
Changes in Fatigue state
Time frame · Day 1, Day 29
Registry description
the mean changes in the Multidimensional Fatigue Inventory (MFI-20) score (MFI-20 is providing an overall score ranging from 20 to 100 (a higher score indicates a higher level of fatigue).
Change in blood lipid profile from baseline during the intervention period
Time frame · Day 1, Day 29
Registry description
Total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride concentrations will be evaluated
Change in blood glucose (fasting) from baseline during the intervention period
Time frame · Day 1, Day 29
Registry description
the McNair Cognitive Difficulty Self Questionnaire
Change from baseline in homocysteine concentrations
Time frame · Day 1, Day 29
Registry description
homocysteine level will be evaluated in plasma
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
PepBank is a research reference. Talk to a doctor before you use any peptide.