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Pharmacokinetic Analysis of Nicotinamide Riboside

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02300740
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : February 27, 2015
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Britt Christensen, Aarhus University Hospital

Tracking Information
First Submitted Date  ICMJE November 20, 2014
First Posted Date  ICMJE November 25, 2014
Last Update Posted Date February 27, 2015
Study Start Date  ICMJE December 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2014)
Serum nicotinamide riboside [ Time Frame: 8 hours, blood samples every 15 min ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Analysis of Nicotinamide Riboside
Official Title  ICMJE Not Provided
Brief Summary Nicotinamide riboside is a newly discovered vitamin B3. The pharmacokinetics in humans is so far not analyzed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Participants
Intervention  ICMJE Dietary Supplement: Nicotinamide riboside
NIAGEN, ChromaDex
Study Arms  ICMJE
  • Experimental: low dose
    500 mg nicotinamide riboside oral
    Intervention: Dietary Supplement: Nicotinamide riboside
  • Experimental: high dose
    1000 mg nicotinamide riboside oral
    Intervention: Dietary Supplement: Nicotinamide riboside
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2015)
12
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2014)
8
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI 18-25, healthy, male,

Exclusion Criteria:

  • liver or kidney diseases, other diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02300740
Other Study ID Numbers  ICMJE 45141
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Britt Christensen, Aarhus University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aarhus University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of Copenhagen
Investigators  ICMJE Not Provided
PRS Account Aarhus University Hospital
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP