Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

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).
    


Intervention name(s): Bupropion; Anastrozole; Testosterone cyclopentylpropionate; Danazol; Chlorthalidone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 300 mg of bupropion hydrochloride (1 tablet) administered orally in a single dose.; 1 mg of anastrozole (1 tablet) administered orally in a single dose.; 100 mg of testosterone cyclopentylpropionate (equivalent to 70 mg of testosterone) administered via intramuscular injection in a single dose (2 mL).; 200 mg of danazol (1 capsule) administered orally in a single dose.; 50 mg of chlorthalidone (1 tablet) administered orally in a single dose.
Other intervention name(s): Elontril®; Anastrozol Mylan®; Testex prolongatum®; Danatrol®; Higrotona®
Intervention MeSH terms: Methyltestosterone; Anastrozole; Chlorthalidone; Bupropion; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate; Danazol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center, non-randomized, unblinded, uncontrolled clinical trial in healthy male volunteers, at a single dose of the five study drugs (bupropion, anastrozole, testosterone cyclopentylpropionate, danazol and chlorthalidone).
Masking: None (Open Label)
Primary purpose: Other
Keywords: Anti-doping control; Bupropion; Anastrozole; Danazol; Chlorthalidone; Testosterone