Drug ToxicityPhase 1NCT06214468
Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity
A Phase 1 study testing Acetaminophen and Nicotinamide Riboside and Acetaminophen in people with Drug Toxicity, run by University of South Alabama at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Toxicity
- What is being tested?
- Acetaminophen and Nicotinamide Riboside and Acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 1 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- n/a
Who cannot join
- Individual allergic to acetaminophen or nicotinamide riboside
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
In space, astronauts are constantly exposed to conditions the body is not used to. To relieve pain and discomfort, astronauts often use acetaminophen. This study investigates a possible negative synergistic effect between using acetaminophen and space-like stressors as they both generate oxidative stress and produce toxins that distribute around the body and disrupt cellular function in other tissues. The study seeks to examine whether a dietary supplement, nicotinamide riboside (NR), can reduce some adverse effects of these toxins by reducing their production when taking acetaminophen.
The study will measure these materials in urine after ingestion of 1 gram of acetaminophen and compare these measurements to when the same amount of acetaminophen is taken at the same time as NR. It will also evaluate whether these toxins are more abundant when blood is placed under conditions resembling space. Therefore, blood collection from a few volunteers who take acetaminophen, and acetaminophen with NR. Ultimately, this work will establish whether NR could reduce the generation of specific endotoxins.
For this study, male and female volunteers are needed to donate urine for testing the effect of 1000mg dose of Tylenol® and one 1000mg dose of Tylenol® with one 250mg dose of Nicotinamide Riboside on the abundance of uremic toxins in urine and in blood. Volunteers are also needed to donate blood.
- Conditions
- Drug Toxicity
- Being tested
- Acetaminophen and Nicotinamide Riboside, Acetaminophen
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen and Nicotinamide RibosideCombination product
Also called Tylenol and Vitamin B3
Collection of urine at different time intervals following ingestion of Tylenol plus Nicotinamide Riboside
AcetaminophenDrug
Also called Tylenol
Collection of urine at different time intervals following ingestion of Tylenol only
| Study group | Role | What they receive |
|---|---|---|
| Tylenol and Nicotinamide Riboside | Other | Not described Receives: Combination Product: Acetaminophen and Nicotinamide Riboside; Drug: Acetaminophen |
| Tylenol Only | Active comparator | Not described Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start15 Jan 2024
- Primary completion1 Apr 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Alabama
- Sponsor type
- University, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA), University of Nevada, Las Vegas, University of Alabama at Birmingham, Rutgers University
- Responsible party
- Principal investigator, Marie Migaud, University of South Alabama
- Investigators
- marie migaud, PHD, Principal investigator, University of South Alabama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214468
- Sponsor's protocol ID
- 23-067/2026659-2
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity
- ClinicalTrials.gov ID
- NCT06214468
- Acronym / sponsor ID
- 23-067/2026659-2
- Conditions
- Drug Toxicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of South AlabamaUniversity, hospital or other
- Collaborators
- National Aeronautics and Space Administration (NASA), University of Nevada, Las Vegas, University of Alabama at Birmingham, Rutgers University
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In space, astronauts are constantly exposed to conditions the body is not used to. To relieve pain and discomfort, astronauts often use acetaminophen. This study investigates a possible negative synergistic effect between using acetaminophen and space-like stressors as they both generate oxidative stress and produce toxins that distribute around the body and disrupt cellular function in other tissues. The study seeks to examine whether a dietary supplement, nicotinamide riboside (NR), can reduce some adverse effects of these toxins by reducing their production when taking acetaminophen.
The study will measure these materials in urine after ingestion of 1 gram of acetaminophen and compare these measurements to when the same amount of acetaminophen is taken at the same time as NR. It will also evaluate whether these toxins are more abundant when blood is placed under conditions resembling space. Therefore, blood collection from a few volunteers who take acetaminophen, and acetaminophen with NR. Ultimately, this work will establish whether NR could reduce the generation of specific endotoxins.
For this study, male and female volunteers are needed to donate urine for testing the effect of 1000mg dose of Tylenol® and one 1000mg dose of Tylenol® with one 250mg dose of Nicotinamide Riboside on the abundance of uremic toxins in urine and in blood. Volunteers are also needed to donate blood.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tylenol and Nicotinamide Riboside | Other | Combination Product: Acetaminophen and Nicotinamide Riboside, Drug: Acetaminophen |
| Tylenol Only | Active comparator | Drug: Acetaminophen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- n/a
Key exclusion criteria (1 listed)
- Individual allergic to acetaminophen or nicotinamide riboside
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetaminophen and Nicotinamide RibosideAlso: Tylenol and Vitamin B3Collection of urine at different time intervals following ingestion of Tylenol plus Nicotinamide Riboside | Combination product | Tylenol and Nicotinamide Riboside |
| AcetaminophenAlso: TylenolCollection of urine at different time intervals following ingestion of Tylenol only | Drug | Tylenol Only, Tylenol and Nicotinamide Riboside |
Primary outcome
Count the quantity of NAD(P)(H) present with exposure to acetaminophen, with and without NR
Time frame: At consent and 6 hours post dose
Multiple blood draws pre and post dose of acetaminophen plus NR
Count the DNA damage occurring upon space-like stressors following exposure to acetaminophen, with and without NR
Time frame: At consent and 6 hours post dose
Multiple blood draws pre and post dose of acetaminophen with or without NR.
Count the quantity of ox-NAD(P) present with exposure to acetaminophen, with and without NR
Time frame: At consent and 6 hours post dose
Multiple blood draws pre and post dose of acetaminophen plus NR
Count the quantity of PYR-ribosides present with exposure to acetaminophen, with and without NR
Time frame: Pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and
A urine sample will be collected from consented volunteers pre and post dose of acetaminophen plus NR
Count the quantity of PYR-nucleotides present with exposure to acetaminophen, with and without NR
Time frame: Pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and
A blood sample will be collected from consented volunteers pre and post dose of acetaminophen plus NR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
marie migaud, PHD principal investigator
University of South Alabama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acetaminophen and Nicotinamide Riboside and Acetaminophen in people with Drug Toxicity, run by University of South Alabama at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count the quantity of NAD(P)(H) present with exposure to acetaminophen, with and without NR (time frame: At consent and 6 hours post dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.