Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity

NCT06214468 | Unknown Phase 1 FDA Drug

• 1 other identifier: 23-067/2026659-2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Over-the-counter drugs like acetaminophen (e.g., Tylenol®) can be detrimental. In space, astronauts who have pain and constant discomfort use acetaminophen extensively. Investigators are studying the effects of acetaminophen under space-like conditions since acetaminophen might affect astronauts' health. Investigators also wish to see whether a dietary supplement can reduce some negative effects of acetaminophen. It is believed that acetaminophen promotes the productions of chemicals in the body that could be toxic. In this study, measurements of these chemicals in urine after ingestion of 1 tablet of acetaminophen and compare these measurements to when acetaminophen is taken at the same time as a dietary supplement. This study will also explore whether these products are more abundant when blood is placed under conditions that mimic space. Therefore, this study will collect blood from a few volunteers who took acetaminophen, and acetaminophen with the dietary supplement.

Conditions

Drug Toxicity

Outcome Measures

Primary Outcomes (5)

• Count the quantity of NAD(P)(H) present with exposure to acetaminophen, with and without NR

  Multiple blood draws pre and post dose of acetaminophen plus NR

  At consent and 6 hours post dose

• Count the DNA damage occurring upon space-like stressors following exposure to acetaminophen, with and without NR

  Multiple blood draws pre and post dose of acetaminophen with or without NR.

  At consent and 6 hours post dose

• Count the quantity of ox-NAD(P) present with exposure to acetaminophen, with and without NR

  Multiple blood draws pre and post dose of acetaminophen plus NR

  At consent and 6 hours post dose

• Count the quantity of PYR-ribosides present with exposure to acetaminophen, with and without NR

  A urine sample will be collected from consented volunteers pre and post dose of acetaminophen plus NR

  Pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and

• Count the quantity of PYR-nucleotides present with exposure to acetaminophen, with and without NR

  A blood sample will be collected from consented volunteers pre and post dose of acetaminophen plus NR

  Pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and

Study Arms (2)

Tylenol and Nicotinamide Riboside

OTHER

Combination Product: Acetaminophen and Nicotinamide Riboside; Drug: Acetaminophen

Tylenol Only

ACTIVE COMPARATOR

Drug: Acetaminophen

Interventions

Acetaminophen and Nicotinamide Riboside COMBINATION_PRODUCT

Collection of urine at different time intervals following ingestion of Tylenol plus Nicotinamide Riboside

Also known as: Tylenol and Vitamin B3

Tylenol and Nicotinamide Riboside

Acetaminophen DRUG

Collection of urine at different time intervals following ingestion of Tylenol only

Also known as: Tylenol

Tylenol Only; Tylenol and Nicotinamide Riboside

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• n/a

You may not qualify if:

• Individual allergic to acetaminophen or nicotinamide riboside

Sponsors & Collaborators

• University of South Alabama: lead
• National Aeronautics and Space Administration (NASA): collaborator
• University of Nevada, Las Vegas: collaborator
• University of Alabama at Birmingham: collaborator
• Rutgers University: collaborator

Study Sites (1)

University of South Alabama

Mobile, Alabama, 36604, United States

RECRUITING

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Acetaminophen; nicotinamide-beta-riboside; Niacinamide

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• marie migaud, PHD

  University of South Alabama

  PRINCIPAL INVESTIGATOR

Central Study Contacts

marie E migaud, PHD

CONTACT

2514104938; mmigaud@southalabama.edu

BENJAMIN CAMPBELL

CONTACT

2513305253; brcampbell@health.southalabams.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sample will be assigned a unique identifier to de-identify samples from the study team. This unique identifier will be assigned by the clinical manager, who will be providing the informed consent. Each sample will be labeled to include gender, race and ethnicity.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacology

Model Details: This study takes place over 2 days, and the study runs twice, two weeks apart. Upon enrolment and consent, the participant will provide a urine sample then be given acetaminophen and Nicotinamide Riboside (NR). Participant are asked to collect 4 urine samples over a 24 hour period and record the time of the collection each time. Two weeks after this first collection, participants are asked to repeat the process but this time with only acetaminophen ingestion. Tubes will be provided for the collection of the urine and zip lock bags will be provided to place the tubes in after samples have been collected. All samples should be stored in the freezer until completion of the samples at which time they should be brought to the USA Mitchell Cancer Institute. Some volunteers will participate in 4 total blood draws collected on the first day at the time of the consent then again 6 hours after taking NR and Acetaminophen. Blood samples will be taken again during the second collection period.

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 19, 2024
• Study Start: January 15, 2024
• Primary Completion: June 15, 2024
• Study Completion: April 30, 2025
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)