<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02191462</url>
  </required_header>
  <id_info>
    <org_study_id>14NBHC</org_study_id>
    <nct_id>NCT02191462</nct_id>
  </id_info>
  <brief_title>A Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects</brief_title>
  <acronym>14NBHC</acronym>
  <official_title>A Randomized, Double-blind, Cross-over Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KGK Science Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ChromaDex, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>KGK Science Inc.</source>
  <brief_summary>
    <textblock>
      The purpose of this study in to analyse the way in which the body processes Niagen&#xD;
      (nicotinamide riboside) in healthy people. Blood and urine samples from subjects who are&#xD;
      given a dose of Niagen will be analyzed for metabolites over the 24 hours after taking the&#xD;
      dose.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>t1/2 (terminal half-life)</measure>
    <time_frame>24 hours</time_frame>
    <description>24 hour dosing period; 3 dosing periods each separated by 7 day washout</description>
  </primary_outcome>
  <other_outcome>
    <measure>Area under the curve (AUC(0-24h)</measure>
    <time_frame>24 hours</time_frame>
    <description>24 hour dosing period; 3 dosing periods each separated by 7 day washout</description>
  </other_outcome>
  <other_outcome>
    <measure>AUCI (AUC to infinity)</measure>
    <time_frame>24 hours</time_frame>
    <description>24 hour dosing period; 3 dosing periods each separated by 7 day washout</description>
  </other_outcome>
  <other_outcome>
    <measure>AUC(0-24h)/AUCI</measure>
    <time_frame>24 hours</time_frame>
    <description>24 hour dosing period; 3 dosing periods each separated by 7 day washout</description>
  </other_outcome>
  <other_outcome>
    <measure>Maximum observed concentration (Cmax)</measure>
    <time_frame>24 hours</time_frame>
    <description>24 hour dosing period; 3 dosing periods each separated by 7 day washout</description>
  </other_outcome>
  <other_outcome>
    <measure>Time of maximum concentration (Tmax),</measure>
    <time_frame>24 hours</time_frame>
    <description>24 hour dosing period; 3 dosing periods each separated by 7 day washout</description>
  </other_outcome>
  <other_outcome>
    <measure>λ (terminal disposition rate constant)</measure>
    <time_frame>24 hours</time_frame>
    <description>24 hour dosing period; 3 dosing periods each separated by 7 day washout</description>
  </other_outcome>
  <other_outcome>
    <measure>AUCReftmax (Area under the curve to tmax)</measure>
    <time_frame>24 hours</time_frame>
    <description>24 hour dosing period; 3 dosing periods each separated by 7 day washout</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Safety parameters</measure>
    <time_frame>24 hour dosing period; pre dose and 24 hr post dose</time_frame>
    <description>CBC</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Safety parameters</measure>
    <time_frame>24 hour dosing period; pre dose and 24 hr post dose</time_frame>
    <description>electrolytes</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Safety parameters</measure>
    <time_frame>24 hour dosing period; pre dose and 24 hr post dose</time_frame>
    <description>glucose</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Safety parameters</measure>
    <time_frame>24 hour dosing period; pre dose and 24 hr post dose</time_frame>
    <description>creatinine</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Safety parameters</measure>
    <time_frame>24 hour dosing period; pre dose and 24 hr post dose</time_frame>
    <description>AST</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Safety parameters</measure>
    <time_frame>24 hour dosing period; pre dose and 24 hr post dose</time_frame>
    <description>ALT</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Safety parameters</measure>
    <time_frame>24 hour dosing period; pre dose and 24 hr post dose</time_frame>
    <description>GGT</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Safety parameters</measure>
    <time_frame>24 hour dosing period; pre dose and 24 hr post dose</time_frame>
    <description>uric acid</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood Safety parameters</measure>
    <time_frame>24 hour dosing period; pre dose and 24 hr post dose</time_frame>
    <description>bilirubin</description>
  </other_outcome>
  <other_outcome>
    <measure>Vital Signs</measure>
    <time_frame>24 hour period: pre-dose, 1h, 4h, 6h, 12h, 24h post-dose</time_frame>
    <description>Heart Rate</description>
  </other_outcome>
  <other_outcome>
    <measure>Vital Signs</measure>
    <time_frame>24 hour period: pre-dose, 1h, 4h, 6h, 12h, 24h post-dose</time_frame>
    <description>Blood Pressure</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Pharmacokinetics</condition>
  <arm_group>
    <arm_group_label>Niagen 100mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 Niagen capsule (1 x 100 mg capsule) and 9 Placebo capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Niagen 300mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 Niagen capsules (3 x 100mg capsule) and 7 Placebo capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1000mg Niagen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 Niagen capsules (10 x 100mg capsule)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Niagen 100mg</intervention_name>
    <arm_group_label>Niagen 100mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Niagen 300mg</intervention_name>
    <arm_group_label>Niagen 300mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Niagen 1000mg</intervention_name>
    <arm_group_label>1000mg Niagen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Male or female age 30-55 years&#xD;
&#xD;
          -  BMI 18.5-29.9 kg/m2&#xD;
&#xD;
          -  If female, subject is not of child bearing potential, OR Females of childbearing&#xD;
             potential must agree to use a medically approved method of birth control and have a&#xD;
             negative urine pregnancy test result.&#xD;
&#xD;
          -  Healthy as determined by laboratory results and medical history&#xD;
&#xD;
          -  Agrees to maintain current level of physical activity throughout the study&#xD;
&#xD;
          -  Agrees to avoid vitamins and St. John's Wort for 30 days prior to enrollment and&#xD;
             during the study&#xD;
&#xD;
          -  Agrees to avoid nutritional yeast, whey proteins, energy drinks, dairy products,&#xD;
             grapefruit and grapefruit juice and alcohol 7 days prior to enrollment and during&#xD;
             study&#xD;
&#xD;
          -  Has given voluntary, written, informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant, breastfeeding, or planning to become pregnant during the&#xD;
             course of the trial.&#xD;
&#xD;
          -  Use of natural health products (NHPs)/dietary supplements within 7 days prior to&#xD;
             randomization and during the course of the study.&#xD;
&#xD;
          -  Use of vitamins or St. John's Wort in the last 30 days before the study enrollment,&#xD;
&#xD;
          -  Use of natural health products containing Nicotinamide riboside within 7 days prior to&#xD;
             randomization and during the course of the study&#xD;
&#xD;
          -  Use of nutritional yeast, whey proteins, energy drinks, grapefruit and grapefruit&#xD;
             juice, dairy products, alcohol for 7 days prior to the study&#xD;
&#xD;
          -  Subjects who are smokers&#xD;
&#xD;
          -  Subjects with blood pressure ≥140/90&#xD;
&#xD;
          -  Use of blood pressure medications&#xD;
&#xD;
          -  Use of cholesterol lowering medications&#xD;
&#xD;
          -  Metabolic diseases or chronic diseases&#xD;
&#xD;
          -  Use of acute over the counter medication within 72 hours of test product dosing&#xD;
&#xD;
          -  Unstable medical conditions as determined by the Qualified Investigator&#xD;
&#xD;
          -  Immunocompromised individuals such as subjects that have undergone organ&#xD;
             transplantation or subjects diagnosed with human immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Clinically significant abnormal lab results at screening (e.g. AST and/or ALT &gt; 2 x&#xD;
             ULN, and/or bilirubin &gt; 2 x ULN) will be assessed by the Medical Investigator&#xD;
&#xD;
          -  Subjects who have planned surgery during the course of the trial&#xD;
&#xD;
          -  History of or current diagnosis of any cancer (except for successfully treated basal&#xD;
             cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer&#xD;
             in full remission more than 5 years after diagnosis are acceptable&#xD;
&#xD;
          -  History of blood/bleeding disorders&#xD;
&#xD;
          -  Blood donation in the past 2 months&#xD;
&#xD;
          -  Alcohol abuse (&gt;2 standard alcoholic drinks per day) or drug abuse within the past 6&#xD;
             months&#xD;
&#xD;
          -  Participation in a clinical research trial within 30 days prior to randomization&#xD;
&#xD;
          -  Allergy or sensitivity to study supplement ingredients or to any food or beverage&#xD;
             provided during the study&#xD;
&#xD;
          -  Individuals who are cognitively impaired and/or who are unable to give informed&#xD;
             consent.&#xD;
&#xD;
          -  Any other condition which in the Investigator's opinion may adversely affect the&#xD;
             subject's ability to complete the study or its measures or which may pose significant&#xD;
             risk to the subject&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dale Wilson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KGK Science Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KGK Synergize Inc.</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>September 8, 2014</last_update_submitted>
  <last_update_submitted_qc>September 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Niagen</keyword>
  <keyword>Nicotinamide riboside</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02191462
org study id: 14NBHC
nct id: NCT02191462
lead sponsor: 
collaborator: 
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.
allocation: Randomized
intervention model: Crossover Assignment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: t1/2 (terminal half-life)
time frame: 24 hours
description: 24 hour dosing period; 3 dosing periods each separated by 7 day washout
measure: Area under the curve (AUC(0-24h)
time frame: 24 hours
description: 24 hour dosing period; 3 dosing periods each separated by 7 day washout
measure: AUCI (AUC to infinity)
time frame: 24 hours
description: 24 hour dosing period; 3 dosing periods each separated by 7 day washout
measure: AUC(0-24h)/AUCI
time frame: 24 hours
description: 24 hour dosing period; 3 dosing periods each separated by 7 day washout
measure: Maximum observed concentration (Cmax)
time frame: 24 hours
description: 24 hour dosing period; 3 dosing periods each separated by 7 day washout
measure: Time of maximum concentration (Tmax),
time frame: 24 hours
description: 24 hour dosing period; 3 dosing periods each separated by 7 day washout
measure: λ (terminal disposition rate constant)
time frame: 24 hours
description: 24 hour dosing period; 3 dosing periods each separated by 7 day washout
measure: AUCReftmax (Area under the curve to tmax)
time frame: 24 hours
description: 24 hour dosing period; 3 dosing periods each separated by 7 day washout
measure: Blood Safety parameters
time frame: 24 hour dosing period; pre dose and 24 hr post dose
description: CBC
measure: Blood Safety parameters
time frame: 24 hour dosing period; pre dose and 24 hr post dose
description: electrolytes
measure: Blood Safety parameters
time frame: 24 hour dosing period; pre dose and 24 hr post dose
description: glucose
measure: Blood Safety parameters
time frame: 24 hour dosing period; pre dose and 24 hr post dose
description: creatinine
measure: Blood Safety parameters
time frame: 24 hour dosing period; pre dose and 24 hr post dose
description: AST
measure: Blood Safety parameters
time frame: 24 hour dosing period; pre dose and 24 hr post dose
description: ALT
measure: Blood Safety parameters
time frame: 24 hour dosing period; pre dose and 24 hr post dose
description: GGT
measure: Blood Safety parameters
time frame: 24 hour dosing period; pre dose and 24 hr post dose
description: uric acid
measure: Blood Safety parameters
time frame: 24 hour dosing period; pre dose and 24 hr post dose
description: bilirubin
measure: Vital Signs
time frame: 24 hour period: pre-dose, 1h, 4h, 6h, 12h, 24h post-dose
description: Heart Rate
measure: Vital Signs
time frame: 24 hour period: pre-dose, 1h, 4h, 6h, 12h, 24h post-dose
description: Blood Pressure
arm group label: Niagen 100mg
arm group type: Experimental
description: 1 Niagen capsule (1 x 100 mg capsule) and 9 Placebo capsules
arm group label: Niagen 300mg
arm group type: Experimental
description: 3 Niagen capsules (3 x 100mg capsule) and 7 Placebo capsules
arm group label: 1000mg Niagen
arm group type: Experimental
description: 10 Niagen capsules (10 x 100mg capsule)
intervention type: Dietary Supplement
intervention name: Niagen 100mg
arm group label: Niagen 100mg
intervention type: Dietary Supplement
intervention name: Niagen 300mg
arm group label: Niagen 300mg
intervention type: Dietary Supplement
intervention name: Niagen 1000mg
arm group label: 1000mg Niagen
criteria: 
gender: All
minimum age: 30 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dale Wilson, MD
role: Principal Investigator
affiliation: KGK Science Inc.
facility: 
country: Canada
responsible party type: Sponsor