Healthy ParticipantsEarly Phase 1NCT02300740
Pharmacokinetic Analysis of Nicotinamide Riboside
A Early Phase 1 study testing Nicotinamide riboside in people with Healthy Participants, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so far not analyzed. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Nicotinamide riboside
- 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 siteDenmark
- Study dates
- Dec 2014to Feb 2015
- Phase
- Early 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-25, healthy, male,
Who cannot join
- liver or kidney diseases, other diseases
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical Research Laboratories, Aarhus University Hospital
Aarhus, 8000
About this study
Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so far not analyzed.
- Conditions
- Healthy Participants
- Being tested
- Nicotinamide riboside
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide ribosideDietary supplement
NIAGEN, ChromaDex
| Study group | Role | What they receive |
|---|---|---|
| low dose | Experimental | 500 mg nicotinamide riboside oral Receives: Dietary Supplement: Nicotinamide riboside |
| high dose | Experimental | 1000 mg nicotinamide riboside oral Receives: Dietary Supplement: Nicotinamide riboside |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum nicotinamide riboside
Measured: 8 hours, blood samples every 15 min
Secondary outcomes (5)
serum concentrations of metabolites of nicotinamide riboside
Measured: 8 hour, blood samples every 15 min
area under the curve for serum nicotinamide riboside
Measured: 8 hours, blood samples every 15 min
calculation of halftime of serum nicotinamide riboside
Measured: 8 hours, blood samples every 15 min
calculation of C-max of serum nicotinamide riboside
Measured: 8 hours, blood samples every 15 min
calculation of t-max of serum nicotinamide riboside
Measured: 8 hours, blood samples every 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Britt Christensen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300740
- Sponsor's protocol ID
- 45141
- Status last verified
- Nov 2014
- First submitted
- 20 Nov 2014
- Last updated
- 27 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Analysis of Nicotinamide Riboside
- ClinicalTrials.gov ID
- NCT02300740
- Acronym / sponsor ID
- 45141
- Conditions
- Healthy Participants
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Dec 2014
- Primary completion
- Feb 2015 (actual)
- First posted
- 25 Nov 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.
Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so far not analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose | Experimental | Dietary Supplement: Nicotinamide riboside500 mg nicotinamide riboside oral |
| high dose | Experimental | Dietary Supplement: Nicotinamide riboside1000 mg nicotinamide riboside oral |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 18-25, healthy, male,
Key exclusion criteria (1 listed)
- liver or kidney diseases, other diseases
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 |
|---|---|---|
| Nicotinamide ribosideNIAGEN, ChromaDex | Dietary supplement | high dose, low dose |
Primary outcome
Serum nicotinamide riboside
Time frame: 8 hours, blood samples every 15 min
5 secondary outcomes
serum concentrations of metabolites of nicotinamide riboside
Time frame: 8 hour, blood samples every 15 min
area under the curve for serum nicotinamide riboside
Time frame: 8 hours, blood samples every 15 min
calculation of halftime of serum nicotinamide riboside
Time frame: 8 hours, blood samples every 15 min
calculation of C-max of serum nicotinamide riboside
Time frame: 8 hours, blood samples every 15 min
calculation of t-max of serum nicotinamide riboside
Time frame: 8 hours, blood samples every 15 min
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 27 Feb 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nicotinamide riboside in people with Healthy Participants, run by Aarhus University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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 27 Feb 2015. 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 Denmark. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Serum nicotinamide riboside (time frame: 8 hours, blood samples every 15 min). 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 27 Feb 2015.