"Pharmacokinetic Study of Nicotinamide Riboside"

University of Washington

Status and phase: Completed; Phase 1

Conditions: Metabolic Disturbance

Treatments: Dietary Supplement: nicotinamide riboside

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02689882

R21HL126209-01S1 (U.S. NIH Grant/Contract)

HL126209-01S1

Details and patient eligibility

About

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.

Full description

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. 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. 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.

On Day 9 prior to receiving their morning dose, participants will be admitted to the UW GCRC for an overnight stay.

In the UW GCRC, the participants will receive the last 1000 mg dose of NR at time=0. Blood samples will be collected at time = 30 minutes and at 1, 2, 3, 4, 6, 8, 12, 16 and 24 hours. Whole blood samples will be frozen at -80 degrees C until assayed for NR and NAD+. "Safety labs" performed on Day 1 will be repeated

Enrollment: 8 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy, adult (age 21-50 years), male or female
• Willing and able to provide informed consent

Exclusion criteria

• Current smoking
• Receiving concurrent medications or supplements
• History of liver, renal, cardiovascular, endocrine, or neurological disease
• Known allergy to niacin or nicotinamide ribosome
• Unwilling to refrain from drinking alcohol during the duration of the study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

pharmacokinetic study

Experimental group

Description:

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.

Treatment:

Dietary Supplement: nicotinamide riboside