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NCT04040465 · ClinicalTrials.gov registry record · Early Phase 1

Asprin Dosing Estimator in Healthy Adults

A Early Phase 1 study, sponsored by University of Utah.

Completed
Registry status
Early Phase 1
Development phase
57
Enrollment target

NCT04040465: Completed Early Phase 1 study, sponsored by University of Utah.

NCT04040465 is a Early Phase 1 study that has completed, run by University of Utah. The registered enrollment target is 57 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04040465, a Early Phase 1 study, has completed, sponsored by University of Utah.

COMPLETED
Registry status
Early Phase 1
Development phase
57 participants
Enrollment target

Study Summary

Understanding sources of variability in human drug dosing is important to the beneficial and safe use of any drug. Understanding and applying the science of individualizing a drug dose to a patient is called precision medicine. Aspirin is one of the oldest most utilized medications for its ability to lower fever, relieve pain, and to reduce the stickiness of platelets (tiny blood cells that help your body form clots to stop bleeding. Aspirin dosing is currently the same for all patients and is not individualized. In the last century, aspirin has shown benefit in reducing cancer, stroke, and preventing cardiovascular events after one has already had a heart attack or stroke. Previous human studies have not found consistent positive effects of aspirin when dosed by body weight. Therefore, how should aspirin be dosed in 2019? Aspirin resistance is the failure of aspirin to reduce platelet stickiness and thin the blood and most importantly, is associated with higher risk of heart attacks and strokes. Aspirin resistance may occur due to not taking aspirin on a regular basis, differences in how platelets behave in some persons, use of over the counter pain medicines like Motrin®, reduced amount of drug in the body, and/or a lack of being able to predict a dose for a certain individual. To find out the best way to dose aspirin, the investigators propose to study healthy volunteers (persons without any known disease) with different ages and body sizes to see if aspirin blood levels are tied to platelet stickiness. This information will be used to mathematically build a computer-based picture of aspirin dosing that will help physicians pick the best dose of aspirin for each patient. The investigators will then extend studies for the aspirin dose estimator to be used in other countries in people with heart problems and stroke, recording future events in a randomized (i.e., coin toss) manner, to determine if the ability of the aspirin dose estimator to prevent future heart a

Primary Outcome

Used to measure BMI

Interventions

  • DRUG Aspirin

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2021-02-15
Est. Completion 2021-10-30
Phase Early Phase 1
University of Utah

818 total trials

What the finished NCT04040465 record still lists

NCT04040465 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which Aspirin is the first listed.

NCT04040465 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04040465 about?

NCT04040465 is a clinical study titled "Asprin Dosing Estimator in Healthy Adults". Understanding sources of variability in human drug dosing is important to the beneficial and safe use of any drug. Understanding and applying the science of individualizing a drug dose to a patient is called precision medicine. Aspirin is one of the oldest most utilized medications for its ability ...

What is the current status of trial NCT04040465?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 57 participants. The study started on 2021-02-15. Estimated completion is 2021-10-30.

What interventions are being tested in trial NCT04040465?

The interventions under investigation include: Aspirin (DRUG).

Who is sponsoring clinical trial NCT04040465?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04040465's enrollment target sits among peer trials

57 446th of 2000 higher than 1,551 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04040465, the US trial registry maintained by the National Library of Medicine. NCT04040465 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.