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CD71 in Dried Blood Spots in Healthy Males

NCT04073849 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-03-17

No results posted yet for this 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

Conditions

  • Healthy Athletes

Interventions

DRUG

EPOGEN® (epoetin alfa)

Active drug

OTHER

Normal Saline

Placebo

Sponsors & Collaborators

  • Sports Medicine Research and Testing Laboratory

    lead INDUSTRY

Principal Investigators

  • Daniel Eichner, PhD · Sports Medicine Research and Testing Laboratory

  • Andre Crouch, MD · Sports Medicine Research and Testing Laboratory

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-15
Primary Completion
2020-11-15
Completion
2020-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04073849 on ClinicalTrials.gov