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"Pharmacokinetic Study of Nicotinamide Riboside"

NCT02689882 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-02-08

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

nicotinamide riboside

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.

Sponsors & Collaborators

Principal Investigators

  • Kevin D O'Brien, MD · University of Washington

  • Rong Tian, MD · University of Washington

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2015-12-31
Completion
2016-02-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02689882 on ClinicalTrials.gov