Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity

23-067/2026659-2

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.

2024-01-15

2024-06-15

2025-04-30

Recruiting

Early phase I

40

Inclusion Criteria: * n/a Exclusion Criteria: * Individual allergic to acetaminophen or nicotinamide riboside

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.\n\nTubes 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.', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

2024-01-19