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Generation of Biological Samples Positive to Fluconazole for Anti-Doping Control

NCT04201054 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-12-16

No results posted yet for this study

Summary

Background:

Androgens are used for doping purpose because they can increase muscle mass and strength. These drugs are included in the list of prohibited substances of the World Anti-Doping Agency (WADA). The prohibition of its use has given rise to a great variety of strategies, including indirect androgenic doping (increasing endogenous testosterone production) or masking of exogenous testosterone administration.

Fluconazole is an imidazole antifungal that inhibits certain cytochrome P-450 dependent enzymes participating in the synthesis of steroid hormones. Concomitant fraudulent administration of testosterone and fluconazole may cause lower steroid concentrations in urine, leading to false negatives in the doping control. Thus, fluconazole may be used in athletes to mask exogenous steroid administration.

Hypothesis:

The oral administration of 12,5 mg of hydrochlorothiazide in healthy subjects allows generating detectable concentrations of the drug in urine. Positive urine samples will enable to identify analytical strategies for doping control.

Objectives:

Primary objective: To measure the concentrations of fluconazole in urine for anti-doping control samples.

Secondary objectives: To identify fluconazole metabolites in urine. To explore the time window in which the drug or its metabolites can be detected in urine after administration. To assess safety and tolerability of the drug used.

Methods:

Phase I, open, non-randomized clinical trial, with a treatment condition (fluconazole) administered in a single oral dose to 2 subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Fluconazole

50 mg of fluconazole administered orally in a single dose.

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Rafael de la Torre Fornell, Dr · IMIM (Hospital del Mar Medical Research Institute)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2019-04-05
Completion
2019-04-05

Countries

  • Spain

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 NCT04201054 on ClinicalTrials.gov