NCT04791345

Study of the Excretion of Orally Administered Corticosteroids for the Improval of the Detection of Said Substances in Anti-doping Controls

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 associated with its consumption. Due to the fact that GC are commercialized in a variety of pharmaceutical forms and are administered in different ways, it is necessary to establish discrimination criteria to guarantee the therapeutic use of these drugs and to prevent doping. Hypothesis: Discrimination criteria between allowed and prohibited administrations of GC must be specific for each of the compounds. Further studies are needed to provide discrimination criteria related to oral administration of GC. Objectives: To conduct excretion studies with dexamethasone, methylprednisolone and deflazacort in order to define notification levels and wash-out periods after the administration of a single dose (DEX, MP and DEF) or repeated doses (DEX and MP) of these drugs. Methods: Non-randomized, open-label, pharmacokinetics clinical trial where a single dose of DEF, MP and DEX and also a multi-dose of DEX and MP will be administered orally to healthy volunteers (total n=50).

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 the use of a unique criteria is not adequate given the diversity of administration routes, doses and pharmacokinetics and pharmacodynamics properties of each drug. The goal of this study is to conduct additional studies using dexamethasone (DEX), methylprednisolone (MP) and deflazacort (DEF) in order to generate additional data of urinary concentrations and wash-out periods after single and repeated oral doses of these drugs.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Methylprednisone	12 mg of methylprednisone (3 pills of 4 mg each) administered orally in a single dose.
DRUG	Methylprednisone	12 mg of methylprednisone (3 pills of 4 mg each) administered orally every 24 hours during 3 days.
DRUG	Deflazacort	30 mg of deflazacort (1 pill) administered orally in a single dose.
DRUG	Dexamethasone	4 mg of dexamethasone (1 pill) administered orally in a single dose.
DRUG	Dexamethasone	2 mg of dexamethasone (1/2 pill) administered orally every 12 hours during 5 days.

Timeline

• Start date: 2021-02-26
• Primary completion: 2022-02-26
• Completion: 2022-02-26
• First posted: 2021-03-10
• Last updated: 2021-04-01

Locations

1 site across 1 country: Spain