"Pharmacokinetic Study of Nicotinamide Riboside"

NCT02689882 | Completed Phase 1 DMC

• 2 other identifiers: HL126209-01S1R21HL126209-01S1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metabolic Disturbance

Keywords

nicotinamide riboside; nicotinamide ribonucleoside; Nicotinamide-Adenine Dinucleotide

Outcome Measures

Primary Outcomes (2)

• Percent change in the average steady state concentration (Css) of nicotinamide riboside (NR) on day 9 (following up titration of nicotinamide riboside to 1000 mg by mouth twice daily) compared to pre-dose baseline.

  Percent change in the average steady state concentration (Css) of nicotinamide riboside (NR) on day 9 (following up titration of nicotinamide riboside to 1000 mg by mouth twice daily) compared to pre-dose baseline. Group mean values will be compared by paired t-test, with correction for multiple primary endpoints.

  9 days

• Percent change in the average steady state concentration (Css) of nicotinamide adenine dinucleotide (NAD) on day 9 (following up titration of nicotinamide riboside to 1000 mg by mouth twice daily) compared to pre-dose baseline.

  Percent change in the average steady state concentration (Css) of nicotinamide adenine dinucleotide (NAD) on day 9 (following up titration of nicotinamide riboside to 1000 mg by mouth twice daily) compared to pre-dose baseline. Group mean values will be compared by paired t-test, with correction for multiple primary endpoints.

  9 days

Secondary Outcomes (5)

• Effect of nicotinamide riboside on serum potassium levels

  9 days

• Effect of nicotinamide riboside on serum creatine kinase levels

  9 days

• Effect of nicotinamide riboside on serum glucose levels

  9 days

• Effect of nicotinamide riboside on serum uric acid levels

  9 days

• Effect of nicotinamide riboside on serum alanine aminotransferase levels

  9 days

Study Arms (1)

pharmacokinetic study

EXPERIMENTAL

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.

Dietary Supplement: nicotinamide riboside

Interventions

nicotinamide riboside DIETARY_SUPPLEMENT

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.

Also known as: Niagen

pharmacokinetic study

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Airhart SE, Shireman LM, Risler LJ, Anderson GD, Nagana Gowda GA, Raftery D, Tian R, Shen DD, O'Brien KD. An open-label, non-randomized study of the pharmacokinetics of the nutritional supplement nicotinamide riboside (NR) and its effects on blood NAD+ levels in healthy volunteers. PLoS One. 2017 Dec 6;12(12):e0186459. doi: 10.1371/journal.pone.0186459. eCollection 2017.

  PMID: 29211728 RESULT

MeSH Terms

Interventions

nicotinamide-beta-riboside

Study Officials

• Kevin D O'Brien, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Rong Tian, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 16, 2016
• First Posted: February 24, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: February 1, 2016
• Last Updated: February 8, 2018

Record last verified: 2018-02

Locations

US (1)