NCT04073849

CD71 in Dried Blood Spots in Healthy Males

Completed EARLY_PHASE1 Last updated 17 March 2021

What this trial tests

EARLY_PHASE1 trial testing EPOGEN® (epoetin alfa) in Healthy Athletes in 24 participants. Completed in 1 December 2020.

Timeline

15 July 2019

Primary endpoint
15 November 2020

1 December 2020

Quick facts

Lead sponsor	Sports Medicine Research and Testing Laboratory
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	24
Start date	15 July 2019
Primary completion	15 November 2020
Estimated completion	1 December 2020
Sites	1 location across United States

Drugs / interventions tested

• EPOGEN® (epoetin alfa) — full drug profile →
• Normal Saline

Conditions studied

• Healthy Athletes — all drugs for Healthy Athletes →

Sponsor

Sports Medicine Research and Testing Laboratory — full company profile →

Who can join

Adults 18 to 45, male only, with Healthy Athletes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The use of RNA-based 5'-aminolevulinate synthase 2 biomarkers in dried blood spots to detect recombinant human erythropoietin microdoses.
   Loria F, Cox HD, Voss SC, Rocca A, et al · · 2022 · cited 16× · PMID 34216436 · DOI 10.1002/dta.3123