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Niacin and Aspirin for Prostaglandin D2 Metabolism Pathways

Phase < 1
Waitlist Available
Led By Claus M Schneider, PhD
Research Sponsored by Vanderbilt University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal, healthy volunteers not currently taking any medication
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-10 hours
Awards & highlights

Study Summary

This trialis studying a previously unknown pathway between two compounds that help with inflammation. It is testing if one of these compounds is made from the other.

Who is the study for?
This trial is for healthy volunteers who aren't on any medications. It's not open to those who've taken anti-inflammatory or over-the-counter pain meds like NSAIDs in the two weeks before the study starts.Check my eligibility
What is being tested?
The study is looking into a potential new pathway between two prostaglandins by giving participants niacin, PGD2, and aspirin to see how these substances affect prostaglandin metabolism.See study design
What are the potential side effects?
Possible side effects from niacin include flushing and itching, aspirin may cause stomach upset or bleeding issues, and PGD2's effects are less known but could involve changes in blood pressure or immune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am healthy and not on any medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-10 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-10 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
prostaglandin metabolites

Trial Design

4Treatment groups
Experimental Treatment
Group I: niacin + regular-strength aspirinExperimental Treatment2 Interventions
Volunteers will provide a urine sample. They will receive 7 tablets of regular-strength aspirin (325 mg) and be instructed to take one tablet daily for 7 days. On the seventh day, they return to have blood drawn, urine collected, and receive niacin as described in arm 1.
Group II: niacin + low-dose aspirinExperimental Treatment2 Interventions
Volunteers will provide a urine sample. They will receive 7 tablets of low-dose aspirin (81 mg) and be instructed to take one tablet daily for 7 days. On the seventh day, they return to have blood drawn, urine collected, and receive niacin as described in arm 1.
Group III: niacinExperimental Treatment1 Intervention
Blood (10 ml) will be drawn from the subject. Immediately before or after the blood draw the subject will collect a urine (3-10 ml) sample. After the baseline blood draw and the urine sample is collected the subject will take 500 mg of niacin. The niacin will not be an extended release formulation. Subjects will be encouraged to drink plenty of water during the study. Subjects are instructed to collect urine 1, 2, 4, 6, 8, and 10 hours after niacin administration. Subjects will collect their urine in separate plastic tubes that will be provided to them. Approximately 1-2 h after niacin administration a second blood sample (10 ml) will be drawn from the subject.
Group IV: deuterated PGD2Experimental Treatment1 Intervention
Volunteers will come to the clinical research center. Volunteers will provide a urine sample. The volunteers will be fitted to record an electrocardiogram (ECG) and blood pressure. ECG will be recorded continuously. Blood pressure will be taken at baseline and every 10 minutes thereafter for one hour. The solution with deuterated PGD2 (10 microgram) will be infused over the course of 30 min. Volunteers will be monitored for 1 h after the end of the infusion, and volunteers will start collecting urine in intervals up to 10 h. Infusion of the deuterated PGD2 solution will be performed in the presence of a physician. The injection solution will be prepared by Vanderbilt University Medical Center (VUMC) Investigational Drug Services. The solution will be sterile and pyrogen free.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
niacin
2003
Completed Phase 4
~390
aspirin
2000
Completed Phase 4
~16940

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor
702 Previous Clinical Trials
6,142,759 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
849 Previous Clinical Trials
669,027 Total Patients Enrolled
Claus M Schneider, PhDPrincipal InvestigatorVanderbilt University

Media Library

PGD2 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04464070 — Phase < 1
Metabolism of Prostaglandin D2 Research Study Groups: deuterated PGD2, niacin + regular-strength aspirin, niacin, niacin + low-dose aspirin
Metabolism of Prostaglandin D2 Clinical Trial 2023: PGD2 Highlights & Side Effects. Trial Name: NCT04464070 — Phase < 1
PGD2 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04464070 — Phase < 1

Frequently Asked Questions

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

Does this research allow for participants that are not yet 20 years of age?

"Eligibility for this study is restricted to patients aged 18-65. However, there are 17 other clinical trials open to participants that are under 18 and 168 trials for seniors."

Answered by AI

What are the benefits of PGD2?

"PGD2 is most commonly used as treatment for percutaneous coronary intervention (pci). However, it has also been taken to treat multiple other conditions such as dental procedures, inflammation, and neck pain."

Answered by AI

Have patients undergone this exact treatment before in other clinical trials?

"To date, there have been 180 ongoing clinical trials for PGD2 in 61 different countries and 1450 cities. The first such trial was sponsored by Sanofi and completed Phase 3 drug approval in 2002 with 413 participants. In the 18 years since then, 510 more trials have completed."

Answered by AI

Are volunteers still needed for this research study?

"According to the latest information available on clinicaltrials.gov, this trial is not presently recruiting new participants. The study was first made public on January 14th, 2021 and received its last update on October 8th, 2022. Even though this particular trial has completed recruitment, there are still 181 other trials that are looking for candidates."

Answered by AI

Who would this trial be most beneficial for?

"This trial is only considering patients that have bleomycin b2 and are between 18-65 years old, with a total of 10 people being accepted into the study."

Answered by AI

How many people are being monitored as part of this research project?

"Unfortunately, this particular study is no longer seeking candidates. The trial was first posted on January 14th, 2021 and was updated for the last time on October 28th, 2022. However, there are 1 clinical trials actively enrolling patients with bleomycin b2 and 180 other studies involving PGD2 that are currently looking for participants."

Answered by AI
~2 spots leftby Mar 2025