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Tylenol and Nicotinamide Riboside for Therapeutic Agent Toxicity

Phase 1

Recruiting

Led By marie migaud, PHD

Research Sponsored by University of South Alabama

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

n/a

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and

Awards & highlights

Study Summary

This trial is studying the effects of acetaminophen (such as Tylenol) on astronauts' health in space. Researchers want to see if acetaminophen can be harmful and if a

Who is the study for?

This trial is for people who use acetaminophen (like Tylenol) to manage pain and discomfort. It's especially relevant for those in conditions similar to space travel, where such drug use is common. Participants must not be allergic to acetaminophen or the dietary supplement nicotinamide riboside.Check my eligibility

What is being tested?

The study tests if a dietary supplement called Nicotinamide Riboside can reduce harmful chemicals produced by taking acetaminophen. Volunteers will take both substances together, and their urine and blood samples will be analyzed under space-like conditions.See study design

What are the potential side effects?

While the side effects of Acetaminophen include liver damage with high doses, adding Nicotinamide Riboside might mitigate these effects. However, potential side effects from this combination are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose and 6 hour, 12 hour and 24 hour post dose following administration and for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Tylenol and Nicotinamide RibosideExperimental Treatment2 Interventions

Group II: Tylenol OnlyActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetaminophen

2017

Completed Phase 4

~2030

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Alabama at BirminghamOTHER

1,590 Previous Clinical Trials

2,281,622 Total Patients Enrolled

University of South AlabamaLead Sponsor

42 Previous Clinical Trials

15,894 Total Patients Enrolled

National Aeronautics and Space Administration (NASA)FED

24 Previous Clinical Trials

1,726 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients currently able to enroll in this ongoing clinical trial?

"Indeed, the details on clinicaltrials.gov indicate that this study is presently in the recruitment phase. It was initially posted on January 15th, 2024 and recently updated on January 9th, 2024. The trial aims to enroll a total of 40 patients from one designated site."

Answered by AI

What is the upper limit on the number of participants engaged in this clinical investigation?

"Indeed, the details on clinicaltrials.gov affirm that this clinical trial is presently enrolling patients. The trial was initially posted on January 15th, 2024 and underwent its most recent update on January 9th, 2024. Recruitment efforts are focused on attaining a cohort of 40 participants from one designated site."

Answered by AI

What is the level of safety associated with Tylenol and Nicotinamide Riboside when administered to individuals?

"Based on the fact that this trial is in Phase 1, indicating limited data supporting safety and efficacy, our team at Power assigns a safety score of 1 to both Tylenol and Nicotinamide Riboside."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity

Marie Migaud 2024. "Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06214468.

All > Toxicity