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Grant Abstract: Safety and Tolerability of the Nutritional Supplement, Nicotinamide Riboside, in Systolic Heart Failure

Grant Number: 1R21HL126209-01
PI Name: Tian
Project Title: Safety and Tolerability of the Nutritional Supplement, Nicotinamide Riboside, in Systolic Heart Failure

Abstract: Supplemental funding is to conduct safety and formal pharmacokinetic (PK) study in healthy volunteers. This information is essential for further research evaluation of the dietary supplement as approved in the grant because the company sponsored PK study reported significant increases in potassium following single doses of nicotinamide riboside (NR) of 100 mg, 300 mg and 1000 mg. Confirmation of NR PK evaluation in healthy volunteers is an important need identified by the IRG and the IRB.
Aim 1: Determine the safety and pharmacokinetics of NR in of 8 adult, healthy male and female participants, ages 21-50, through a multiple dose study of NR. To accomplish this Aim:
A) Participants will be excluded if they are smokers, pregnant, receiving concurrent medications or supplements, have a history of liver, renal, cardiovascular, endocrine, neurological disease or known allergies to niacin or nicotinamide and are not willing to refrain from drinking alcohol during the duration of the Study.
B) On Day 1, patients will have a baseline assessment, including BP, HR, as well as baseline assessment of “safety” labs: CBC with WBC differential and platelets, serum chemistry panel (sodium, potassium, chloride, glucose, blood urea nitrogen and creatinine), uric acid, CPK, AST and ALT, and LDH.
C) Participants will receive 125 mg twice daily on Days 1-2, 250 mg twice daily on Days 3-4, 500 mg twice daily on Days 5-6 and 1000 mg twice daily on Days 7-8.
D) On Day 2, a blood sample will be obtained to measure serum chemistry panel to assess for the possibility of hyperkalemia.
E) On Day 9 prior to receiving their morning dose, participants will be admitted to the General Clinical Research Center at the University of Washington for an overnight stay.
a. In the GCRC, the participants will receive the last 1000 mg dose of NR at t=0.
b. Blood samples will be collected at t= 0.30, 1, 2, 3, 4, 6, 8, 12, 16 and 24 h.
c. Serum samples will be frozen at -70oC until assayed for NR using LCMS/MS.
d. Buffy coat samples also will be obtained to assay for NAD and NADH.
e. “Safety labs” performed on Day 1 will be repeated

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