Pharmacokinetic Analysis of Nicotinamide Riboside
Sponsor
Aarhus University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02300740
Collaborator
University of Copenhagen (Other)
12
1
2
Study Details
Study Description
Brief Summary
Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so far not analyzed.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date
:
Dec 1, 2014
Actual Primary Completion Date
:
Feb 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: low dose 500 mg nicotinamide riboside oral |
Dietary Supplement: Nicotinamide riboside
NIAGEN, ChromaDex
|
| Experimental: high dose 1000 mg nicotinamide riboside oral |
Dietary Supplement: Nicotinamide riboside
NIAGEN, ChromaDex
|
Outcome Measures
Primary Outcome Measures
- Serum nicotinamide riboside [8 hours, blood samples every 15 min]
Secondary Outcome Measures
- serum concentrations of metabolites of nicotinamide riboside [8 hour, blood samples every 15 min]
- area under the curve for serum nicotinamide riboside [8 hours, blood samples every 15 min]
- calculation of halftime of serum nicotinamide riboside [8 hours, blood samples every 15 min]
- calculation of C-max of serum nicotinamide riboside [8 hours, blood samples every 15 min]
- calculation of t-max of serum nicotinamide riboside [8 hours, blood samples every 15 min]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 30 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- BMI 18-25, healthy, male,
Exclusion Criteria:
- liver or kidney diseases, other diseases
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical Research Laboratories, Aarhus University Hospital | Aarhus | Denmark | 8000 |
Sponsors and Collaborators
- Aarhus University Hospital
- University of Copenhagen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Britt Christensen,
Cand.Scient, PhD, Post doc,
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT02300740
Other Study ID Numbers:
- 45141
First Posted:
Nov 25, 2014
Last Update Posted:
Feb 27, 2015
Last Verified:
Nov 1, 2014