Clinical trial NCT02191462: A Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects
Official title: A Randomized, Double-blind, Cross-over Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: Pharmacokinetics
Niagen
Nicotinamide riboside
Lead sponsor: KGK Science Inc.
Sponsor class: INDUSTRY
Collaborators: name: ChromaDex, Inc.
First posted: 2014-07-16
Enrollment: 12
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study in to analyse the way in which the body processes Niagen (nicotinamide riboside) in healthy people. Blood and urine samples from subjects who are given a dose of Niagen will be analyzed for metabolites over the 24 hours after taking the dose.


Eligibility criteria: Inclusion Criteria:

* Healthy Male or female age 30-55 years
* BMI 18.5-29.9 kg/m2
* If female, subject is not of child bearing potential, OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
* Healthy as determined by laboratory results and medical history
* Agrees to maintain current level of physical activity throughout the study
* Agrees to avoid vitamins and St. John's Wort for 30 days prior to enrollment and during the study
* Agrees to avoid nutritional yeast, whey proteins, energy drinks, dairy products, grapefruit and grapefruit juice and alcohol 7 days prior to enrollment and during study
* Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

* Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
* Use of natural health products (NHPs)/dietary supplements within 7 days prior to randomization and during the course of the study.
* Use of vitamins or St. John's Wort in the last 30 days before the study enrollment,
* Use of natural health products containing Nicotinamide riboside within 7 days prior to randomization and during the course of the study
* Use of nutritional yeast, whey proteins, energy drinks, grapefruit and grapefruit juice, dairy products, alcohol for 7 days prior to the study
* Subjects who are smokers
* Subjects with blood pressure ≥140/90
* Use of blood pressure medications
* Use of cholesterol lowering medications
* Metabolic diseases or chronic diseases
* Use of acute over the counter medication within 72 hours of test product dosing
* Unstable medical conditions as determined by the Qualified Investigator
* Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
* Clinically significant abnormal lab results at screening (e.g. AST and/or ALT \> 2 x ULN, and/or bilirubin \> 2 x ULN) will be assessed by the Medical Investigator
* Subjects who have planned surgery during the course of the trial
* History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable
* History of blood/bleeding disorders
* Blood donation in the past 2 months
* Alcohol abuse (\>2 standard alcoholic drinks per day) or drug abuse within the past 6 months
* Participation in a clinical research trial within 30 days prior to randomization
* Allergy or sensitivity to study supplement ingredients or to any food or beverage provided during the study
* Individuals who are cognitively impaired and/or who are unable to give informed consent.
* Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Primary outcomes:
measure: t1/2 (terminal half-life)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
measure: Area under the curve (AUC(0-24h)
timeFrame: 24 hours
measure: AUCI (AUC to infinity)
timeFrame: 24 hours
measure: AUC(0-24h)/AUCI
timeFrame: 24 hours
measure: Maximum observed concentration (Cmax)
timeFrame: 24 hours
measure: Time of maximum concentration (Tmax),
timeFrame: 24 hours
measure: λ (terminal disposition rate constant)
timeFrame: 24 hours
measure: AUCReftmax (Area under the curve to tmax)
timeFrame: 24 hours
measure: Blood Safety parameters
timeFrame: 24 hour dosing period; pre dose and 24 hr post dose
measure: Blood Safety parameters
timeFrame: 24 hour dosing period; pre dose and 24 hr post dose
measure: Blood Safety parameters
timeFrame: 24 hour dosing period; pre dose and 24 hr post dose
measure: Blood Safety parameters
timeFrame: 24 hour dosing period; pre dose and 24 hr post dose
measure: Blood Safety parameters
timeFrame: 24 hour dosing period; pre dose and 24 hr post dose
measure: Blood Safety parameters
timeFrame: 24 hour dosing period; pre dose and 24 hr post dose
measure: Blood Safety parameters
timeFrame: 24 hour dosing period; pre dose and 24 hr post dose
measure: Blood Safety parameters
timeFrame: 24 hour dosing period; pre dose and 24 hr post dose
measure: Blood Safety parameters
timeFrame: 24 hour dosing period; pre dose and 24 hr post dose
measure: Vital Signs
timeFrame: 24 hour period: pre-dose, 1h, 4h, 6h, 12h, 24h post-dose
measure: Vital Signs
timeFrame: 24 hour period: pre-dose, 1h, 4h, 6h, 12h, 24h post-dose
Locations:
city: London
country: Canada
facility: KGK Synergize Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: Dale Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References: