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| Name | Class |
|---|---|
| Dicentra Inc. | INDUSTRY |
| LGD | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMN-C | Experimental | Healthy individuals receiving NMN-C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide mononucleotide (NMN-C) | Dietary Supplement | Daily supplementation with NMN-C at 400 mg for 29 days in total |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in NAD+ and NMN concentrations in whole blood | 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 | Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitalabs Clinic | Toronto | Ontario | M5S 2B7 | Canada |
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| ID | Term |
|---|---|
| D009537 | Nicotinamide Mononucleotide |
| ID | Term |
|---|---|
| D012265 | Ribonucleotides |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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A single-arm, non-randomized, non-controlled, monocenter repeated-dose study
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| Change from baseline in NAD+ and NMN concentrations in whole blood |
NAD+ and NMN will be assessed in blood |
| Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30 |
| Change from baseline in NAD+ metabolites concentrations in plasma | 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 | 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 | MeNAM and NAM will be assessed 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 | 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 | 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 urine | MeNAM and Me-2-PY will be assessed in urine | Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30 |
| Change from baseline in NAD+ and NMN concentrations in whole blood | 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 | Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29 |
| Change from baseline in NAD+ metabolites concentrations in plasma | 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 | Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29 |
| Change from baseline in NAD+ metabolites concentrations in urine | 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 | Pre-dose and at 0.25, 0.5, 1, 2, 4, 8, 12 hour post-dose on Day 29 |
| Changes in body weight | Day 1, Day 29 |
| Tolerance | The number of participants with Adverse Events | Day 1, Day 2, Day 8, Day 15, Day 22, Day 29, Day 30 |
| Changes in Quality of life | 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) | Day 1, Day 29 |
| Changes in Sleep quality | 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) | Day 1, Day 29 |
| Changes in Fatigue state | 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). | Day 1, Day 29 |
| Change in blood lipid profile from baseline during the intervention period | Total cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride concentrations will be evaluated | Day 1, Day 29 |
| Change in blood glucose (fasting) from baseline during the intervention period | the McNair Cognitive Difficulty Self Questionnaire | Day 1, Day 29 |
| Change from baseline in homocysteine concentrations | homocysteine level will be evaluated in plasma | Day 1, Day 29 |