NCT04073849

CD71 in Dried Blood Spots in Healthy Males

Evaluation of CD71 Expression in a Dried Blood Spot Following rEPO Administration

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sports Medicine Research and Testing Laboratory · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

Despite being banned by the World Anti-Doping Agency, blood doping is a common method of performance enhancement used by athletes wishing to gain an unfair advantage over their competition. A common way to achieve this increase is by using erythropoiesis stimulating agents (ESA's), namely recombinant erythropoietin (rEPO). Though laboratory tests have been developed for the direct detection of all known isoforms of exogenously administered ESAs in both urine and blood, athletes have found ways to circumvent these testing measures using techniques such as microdosing.

Conditions

• Healthy Athletes

Interventions

Type	Name	Description
DRUG	EPOGEN® (epoetin alfa)	Active drug
OTHER	Normal Saline	Placebo

Timeline

• Start date: 2019-07-15
• Primary completion: 2020-11-15
• Completion: 2020-12-01
• First posted: 2019-08-29
• Last updated: 2021-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study