Status:
UNKNOWN
Study of the Excretion of Orally Administered Corticosteroids for the Improval of the Detection of Said Substances in Anti-doping Controls
Lead Sponsor:
Parc de Salut Mar
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Background: Glucocorticoids (GC) were included in the list of banned substances in sports in 1986, because of evidences of positive effects on physical performance and the important health risks asso...
Detailed Description
The World Anti-Doping Agency (WADA) has established a general notification level of 30 ng/mL for GC to discriminate allowed and not allowed administrations. However, recent studies have proven that th...
Eligibility Criteria
Inclusion
- Male volunteers aged between 18 and 55 years.
- Able to understand and accept the trial procedures and able to sign an informed consent prior to any study-mandated procedure.
- History and physical examination that demonstrate not presenting organic or psychiatric disorders.
- ECG, blood and urine tests performed before the experimental session within normal limits. Minor or occasional variations of these limits will be allowed if, in the opinion of the Principal Investigator and taking into account the state of science, they have no clinical significance, do not pose a risk to the subject and do not interfere in the product evaluation. These variations and their non-relevance will be specifically justified in writing.
- Body mass index (weight/height\^2) between 19 and 27 kg/m2 and weight between 50 and 100 kg. BMI of 27-28 kg/m2 may be included according to Principal Investigator's criteria.
Exclusion
- Failure to meet inclusion criteria.
- History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to glucocorticoids or any of the excipients. Serious adverse reactions to any drug.
- Contraindications to treatment with study drugs (according to the respective summary of product characteristics, SmPC).
- Clinical background or evidence of gastrointestinal, hepatic, renal disorder or others that may involve an alteration of the absorption, distribution, metabolism or excretion of the drug.
- Clinical background or evidence of psychiatric disorders, alcoholism, drug abuse or habitual consumption of psychoactive drugs.
- Having participated in another clinical trial with medication in the three months prior to the start of the study.
- Having donated blood in the three months prior to the start of the study, in the event that blood extractions are made.
- Having suffered some organic disease or major surgery in the six months prior to the start of the study.
- Clinical background or evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological, or other acute or chronic diseases that, in the opinion of the Principal Investigator or the collaborators designated by him/her, may pose a risk to the subjects or may interfere with the objectives of the study. Especially osteoporosis, hypertension, Cushing syndrome, diabetes mellitus, and viral infections such as herpes or varicella.
- Having taken medication regularly in the month prior to the study sessions -in case of glucocorticoids 3 months prior- with the exception of vitamins, herbal remedies or dietary supplements that, in the opinion of the Principal Investigator or the collaborators designated by him/her, may not pose a risk to the subjects or may not interfere with the objectives of the study. Treatment with a single dose of symptomatic medication in the week prior to the study sessions will not be a reason for exclusion if it is assumed that the drug has been completely eliminated on the day of the experimental session.
- Smokers of more than 20 cigarettes a day in the 3 months before the study.
- Consumption of more than 40 g of alcohol daily.
- Consumers of more than 5 coffees, teas, cola drinks, or other stimulant drinks or with xanthines daily in the 3 months prior to the study start.
- Being unable to understand the nature, consequences of the trial and the procedures that are asked to follow.
- Positive serology for hepatitis B, C or HIV.
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 26 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04791345
Start Date
February 26 2021
End Date
February 26 2022
Last Update
April 1 2021
Active Locations (1)
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1
IMIM (Hospital del Mar Medical Research Institute)
Barcelona, Spain, 08003