"Pharmacokinetic Study of Nicotinamide Riboside"
Condition: Metabolic Disturbance
Study type: Interventional
Phase: Phase 1

Summary: 
      Nicotinamide riboside (NR) has been available over the counter as a nutraceutical (Niagen®,
      ChromaDex, Inc.) since the summer of 2013. However, classical pharmacokinetic (PK) data for
      NR have not been reported in humans. This study will use a recently-developed, whole blood
      assay for NR to assess the pharmacokinetics of NR at a maximum dose of 1000 mg twice daily,
      and will collect history, physical examination and laboratory data to determine the safety
      and tolerability of NR in eight, healthy volunteers. In addition, whole blood nicotinamide
      adenine dinucleotide (NAD) levels will be measured at each time point, to determine whether
      this NR dose significantly raises whole blood NAD levels.
    

Detailed description: 
      1. On Day 1, participants will have a baseline assessment, including blood pressure and
           heart rate, as well as baseline assessment of "safety" labs: complete blood count with
           white blood count differential and platelets, serum chemistry panel (sodium, potassium,
           chloride, glucose, blood urea nitrogen and creatinine), uric acid, creatine kinase,
           aspartate aminotransferase and alanine aminotransferase, and lactate dehydrogenase.

        2. Participants will receive 250 mg nicotinamide riboside (NR) by mouth daily on Days 1-2,
           250 mg NR by mouth twice daily on Days 3-4, 500 mg NR twice daily by mouth on Days 5-6
           and 1000 mg NR twice daily by mouth on Days 7-8.

        3. On Day 2, a blood sample will be obtained from each participant to measure serum
           chemistry panel to assess for the possibility of hyperkalemia and hyperglycemia. In
           addition, an instant read potassium will be measured using a point-of-care device
           available on the University of Washington (UW) General Clinical Research Center (GCRC).
           If the potassium is greater than 5.5, a repeat value and an ECG will be performed and
           the Study Investigator. If it is greater than 6.0, the Study Investigator will evaluate
           the subject for admission.

        4. On Day 9 prior to receiving their morning dose, participants will be admitted to the UW
           GCRC for an overnight stay.

             1. In the UW GCRC, the participants will receive the last 1000 mg dose of NR at
                time=0.

             2. Blood samples will be collected at time = 30 minutes and at 1, 2, 3, 4, 6, 8, 12,
                16 and 24 hours.

             3. Whole blood samples will be frozen at -80 degrees C until assayed for NR and NAD+.

             4. "Safety labs" performed on Day 1 will be repeated
    

Intervention name(s): nicotinamide riboside
Intervention type(s): Dietary Supplement
Intervention description(s): Nicotinamide riboside dose up-titration: Days 1 and 2: 250 mg by mouth daily; Days 3 and 4: 250 mg by mouth twice daily; Days 5 and 6: 500 mg by mouth twice daily; Days 7 and 8: 1000mg by mouth twice daily; Day 9: single dose of 1000mg by mouth followed by 24 hour pharmacokinetic study.
Other intervention name(s): Niagen
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: nicotinamide riboside; nicotinamide ribonucleoside; Nicotinamide-Adenine Dinucleotide