Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers.
Status:
Completed
Trial end date:
2021-03-10
Target enrollment:
Participant gender:
Summary
Background:
The use of stimulants such as bupropion, enzyme inhibitors such as anastrozole, androgens
such as testosterone, antigonadotropins such as danazol, and diuretics such as chlorthalidone
have been reported in urine drug testing programs for a wide variety of applications,
including anti-doping tests in sport. These substances are subject to screening studies by
the World Anti-Doping Agency (WADA). Anastrozole, chlorthalidone, testosterone and danazol
are included on the WADA list of prohibited substances, while bupropion is included in the
2020 follow-up schedule of substances.
This study aims to characterize the urinary excretion patterns of these substances following
the administration of a single dose of each drug at a recommended therapeutic dose.
Hypothesis:
The administration of bupropion, anastrozole, testosterone, danazol or chlorthalidone in
healthy subjects allows the generation of detectable concentrations of the drug in urine
using the liquid chromatography technique coupled to mass spectrometry (LC-MS). Positive
urine samples will enable to identify analytical strategies for doping control.
Objectives:
Primary objective: To measure the concentrations of various drugs (anastrozole, bupropion,
chlorthalidone, danazol and testosterone) and their metabolites in urine for anti-doping
control samples. The detection of new metabolites excreted in urine for longer periods of
time than conventional metabolites will improve the ability to detect the abuse of anabolic
steroids in sport.
Secondary objective: To assess safety and tolerability of the drugs used.
Methods:
Phase I, unicentric, open, non-randomized, non-controlled clinical trial, with 5 parallel
treatment conditions (anastrozole, bupropion, chlorthalidone, danazol and testosterone)
administered in a single dose to male healthy volunteers (total n=11).