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NCT04073849 · ClinicalTrials.gov registry record · Early Phase 1
CD71 in Dried Blood Spots in Healthy Males
A Early Phase 1 study of Healthy Athletes, sponsored by Sports Medicine Research and Testing Laboratory.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04073849: Completed Early Phase 1 study of Healthy Athletes, sponsored by Sports Medicine Research and Testing Laboratory.
NCT04073849 is a Early Phase 1 study of Healthy Athletes that has completed, run by Sports Medicine Research and Testing Laboratory. The registered enrollment target is 24 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04073849, a Early Phase 1 study of Healthy Athletes, has completed, sponsored by Sports Medicine Research and Testing Laboratory.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Understand the effect of recombinant EPO (rEPO) boosting and microdosing on the hematological module of the Athlete Biological Passport (ABP) * Measure the change in CD71 longitudinally in subjects from both cohorts * Assess whether rEPO administration can be detected in a dried blood spot (DBS) using recent advances in analytical methodologies * Compare windows of rEPO detection using both Athlete Biological Passport models and direct detection using analytical methods in urine, blood, and DBS
Primary Outcome
CD71 concentration will be measured during and following administration and will be compared to established baseline values from each individual and the study population to understand the changes caused by this dosing pattern of rEPO. These data, especially when comparing to the variability in CD71 in the placebo cohort, may be extrapolated in the anti-doping framework to detect rEPO abuse by athletes.
Conditions Studied
Interventions
- OTHER Normal Saline
- DRUG EPOGEN® (epoetin alfa)
Study Locations (1)
Utah
- Sports Medicine Research and Testing Laboratory - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-07-15 |
| Est. Completion | 2020-12-01 |
| Phase | Early Phase 1 |
What the finished NCT04073849 record still lists
NCT04073849 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Healthy Athletes appearing as the primary indexed condition, and to 2 interventions - of which Normal Saline is the first listed.
NCT04073849 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT04073849 about?
NCT04073849 is a clinical study titled "CD71 in Dried Blood Spots in Healthy Males". Understand the effect of recombinant EPO (rEPO) boosting and microdosing on the hematological module of the Athlete Biological Passport (ABP) * Measure the change in CD71 longitudinally in subjects from both cohorts * Assess whether rEPO administration can be detected in a dried blood spot (DBS) us...
What is the current status of trial NCT04073849?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 24 participants. The study started on 2019-07-15. Estimated completion is 2020-12-01.
What conditions does trial NCT04073849 study?
This clinical trial studies the following conditions: Healthy Athletes.
What interventions are being tested in trial NCT04073849?
The interventions under investigation include: Normal Saline (OTHER), EPOGEN® (epoetin alfa) (DRUG).
Who is sponsoring clinical trial NCT04073849?
This trial is sponsored by Sports Medicine Research and Testing Laboratory, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04073849 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04073849's enrollment target sits among peer trials
24 1037th of 2000 higher than 914 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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