CD71 in Dried Blood Spots in Healthy Males

NCT04073849 | Completed Early Phase 1 FDA Drug

• 1 other identifier: SMRTL-2018_02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• CD71 (transferrin receptor) concentration

  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.

  8 months

• Hemogloblin concentration

  Hemoglobin 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

  8 months

• Reticulocyte percentage (Ret%)

  Ret% 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

  8 months

• Calculated OFF-score

  Calculated using the formula: OFF-score = Hgb - 60\*√Ret%, OFF-score will be calculated from each collection 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

  8 months

• Immature reticuocyte fraction

  The immature reticulocyte fraction (IRF) 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.

  8 months

Secondary Outcomes (2)

• Window of detection (detectability time) following rEPO use

  12 months

• Analytical detection of rEPO in a dried blood spot

  12 months

Study Arms (2)

Cohort A

ACTIVE COMPARATOR

EPOGEN® (epoetin alfa) Study Drug Epoetin Alfa (EPOGEN®) 40 IU / kg dose during boosting phase, delivered s.c.; 8 injections 900 IU dose during microdosing, delivered i.v.; 6 injections

Drug: EPOGEN® (epoetin alfa)

Cohort B

SHAM COMPARATOR

Saline 40 IU / kg dose during boosting phase, delivered s.c.; 8 injections 900 IU dose during microdosing, delivered i.v.; 6 injections

Other: Normal Saline

Interventions

EPOGEN® (epoetin alfa) DRUG

Active drug

Also known as: erythropoietin, rEPO

Cohort A

Normal Saline OTHER

Placebo

Also known as: Saline

Cohort B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Participants should have ferritin \> 35 ng/mL and transferrin saturation \> 20% at the time of enrollment

You may not qualify if:

• Individuals with the intent to compete in sanctioned athletic events during the study period
• Unwillingness to provide urine samples or blood samples
• Not actively exercising
• Individuals who show a high risk for MI/CAD, stroke, CHF, and venous thromboembolism (VTE)., as defined by the Principal Investigator
• Individuals with known drug allergies
• Individuals with EKG abnormalities, as determined by the Principal Investigator
• Individuals who have chronic kidney disease, HIV, cancer, hepatitis B, hepatitis C, or are planning surgery during the study
• Individuals with history of acute or chronic medical or psychiatric condition
• GFR (Creatinine clearance) \<60 mL/min
• Ferritin \>270 ng/mL
• Individuals who have a baseline hemoglobin concentration greater than 15.5 g/dL or a baseline hematocrit above 47%
• Individuals with blood or iron disorders, including polycythemia, hemochromatosis, anemia, or iron-deficiency anemia
• Individuals with a history of bleeding or bone marrow aplasia
• Individuals who are diabetic or with a history of cardiac or hepatic disease or history of drug abuse

Sponsors & Collaborators

• Sports Medicine Research and Testing Laboratory: lead

Study Sites (1)

Sports Medicine Research and Testing Laboratory

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Interventions

Epoetin Alfa; Erythropoietin; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Daniel Eichner, PhD

  Sports Medicine Research and Testing Laboratory

  STUDY DIRECTOR

• Andre Crouch, MD

  Sports Medicine Research and Testing Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Online randomization tool
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohort A to receive active drug Cohort B to receive placebo, (saline)

Study Record Dates

• First Submitted: July 28, 2019
• First Posted: August 29, 2019
• Study Start: July 15, 2019
• Primary Completion: November 15, 2020
• Study Completion: December 1, 2020
• Last Updated: March 17, 2021

Record last verified: 2019-03

Locations

US (1)