PharmacokineticsPhase 114NBHCNCT02191462
A Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects
A Phase 1 study testing Niagen 100mg, Niagen 300mg and Niagen 1000mg in people with Pharmacokinetics, run by KGK Science Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Niagen 100mg, Niagen 300mg and Niagen 1000mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Cross-over Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects
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.
- Conditions
- Pharmacokinetics
- Being tested
- Niagen 100mg, Niagen 300mg, Niagen 1000mg
- Keywords
- Pharmacokinetics, Niagen, Nicotinamide riboside
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niagen 100mgDietary supplement
Niagen 300mgDietary supplement
Niagen 1000mgDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Niagen 100mg | Experimental | 1 Niagen capsule (1 x 100 mg capsule) and 9 Placebo capsules Receives: Dietary Supplement: Niagen 100mg |
| Niagen 300mg | Experimental | 3 Niagen capsules (3 x 100mg capsule) and 7 Placebo capsules Receives: Dietary Supplement: Niagen 300mg |
| 1000mg Niagen | Experimental | 10 Niagen capsules (10 x 100mg capsule) Receives: Dietary Supplement: Niagen 1000mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
t1/2 (terminal half-life)
24 hour dosing period; 3 dosing periods each separated by 7 day washout
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ChromaDex, Inc.
- Responsible party
- Sponsor
- Investigators
- Dale Wilson, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191462
- Sponsor's protocol ID
- 14NBHC
- Acronym
- 14NBHC
- Status last verified
- Sep 2014
- First submitted
- 11 Jul 2014
- Last updated
- 9 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Cross-over Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02191462
- Acronym / sponsor ID
- 14NBHC / 14NBHC
- Conditions
- Pharmacokinetics
- Keywords
- Pharmacokinetics, Niagen, Nicotinamide riboside
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- ChromaDex, Inc.
- Study start
- Jul 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Niagen 100mg | Experimental | Dietary Supplement: Niagen 100mg1 Niagen capsule (1 x 100 mg capsule) and 9 Placebo capsules |
| Niagen 300mg | Experimental | Dietary Supplement: Niagen 300mg3 Niagen capsules (3 x 100mg capsule) and 7 Placebo capsules |
| 1000mg Niagen | Experimental | Dietary Supplement: Niagen 1000mg10 Niagen capsules (10 x 100mg capsule) |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niagen 100mg | Dietary supplement | Niagen 100mg |
| Niagen 300mg | Dietary supplement | Niagen 300mg |
| Niagen 1000mg | Dietary supplement | 1000mg Niagen |
Primary outcome
t1/2 (terminal half-life)
Time frame: 24 hours
24 hour dosing period; 3 dosing periods each separated by 7 day washout
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dale Wilson, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Niagen 100mg, Niagen 300mg and Niagen 1000mg in people with Pharmacokinetics, run by KGK Science Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
t1/2 (terminal half-life) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2014.