Generation of Positive Biological Samples to Epoetin for Doping Control.

The study consists of generation of biological samples (in blood and urine) positive to Epoetin alfa for laboratories that wish to perform the analysis of doping controls and maintain accreditation from World Anti-Doping Agency.

Study Overview

• Status: Completed
• Conditions: There Are no Conditions Under Study. Healthy Volunteers
• Intervention / Treatment: Drug: EPOETIN ALFA

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Healthy male volunteers aged from 18 to 50 years.
2. A health profile devoid of organic or physiological disorders.
3. The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
4. Body mass index (BMI=weigh/height2) will range between 19 and 27 Kg/m2 and weight between 50 and 110 kg.
5. Understanding and accepting the study procedures and signing the informed consent form.

Exclusion Criteria:

1. Non compliance of the inclusion criteria.
2. Having suffered any organic disease or major surgery in the three months prior to start this study.
3. A prior history of or presence of significant cardiovascular, neurological, haematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease that, in the investigator's opinion, considering the current state of the art, they are clinically significant, are life-threatening for the subjects and could interfere with the product assessment; or which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
4. History or clinical evidence of psychiatric disorders, alcoholism, drug abuse, or regular use of psychoactive drugs.
5. History of hypertension, seizures, endocrine disorders (such as diabetes and hypothyroidism), coagulation disorders, kidney and/or liver disease.
6. Subjects for which the drug involved in the study is counter indicated.
7. Smokers of more than 20 cigarettes per day.
8. Taking more than 35 g of alcohol per day.
9. Drinking more than 5 drinks containing xanthines per day.
10. Regular use of any drug in the month prior to the study sessions. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
11. Have taken part in studies with blood donation in the last 8 weeks prior to start this study.
12. History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance or any excipients.
13. Have been volunteer in another study with drugs in the last 3 months prior to start this study.
14. Subjects with positive serology for hepatitis B, C or HIV.
15. Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EPOETIN ALFA	Drug: EPOETIN ALFA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood and urine concentrations of Epoetin alfa	Urine samples will be collected in different time periods: -48 to -24h, - 24h to 0h (pre-administration), 0 to 24h, 24 to 48h, 48 to 72h, 72 to 96h, 96 to 120h and 120 to 144h (post-administration). 10 mL of blood and dried blood spot (DBS) microvolume sampling with FTA DMPK -C cards will be collected at different time points: 48-72 hours before the first administration of the drug, before administration (0h, baseline), at 24, 48, 72 and 96 hours after administration of the drug. In session 5, blood samples will be collected at 0h (pre-administration) and at 1h, 4h and 8h after the administration of the drug.	From 48-72 hours pre-administration to 144 hours post administration

Collaborators and Investigators

• Sponsor: Parc de Salut Mar

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2016
• Primary Completion (Actual): January 17, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: September 29, 2016
• First Submitted That Met QC Criteria: September 29, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematinics; Epoetin Alfa
• Other Study ID Numbers: IMIMFTCL/EPO; 2016-002866-29 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No