CompletedPhase 1

Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers.

Spain9 participantsStarted 2020-12-03

Plain-language 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).

Who can participate

Age range

18 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male volunteers aged between 18 and 50 years. * Able to understand and accept the trial procedures and able to sign an informed consent. * 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 Criteria: * Failure to meet inclusion criteria. * History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance or any of the excipients. Lactose intolerance. Serious adverse reactions to any drug. * Contraindications to treatment with study drugs (according to the respective summary of product characteristics, SmPC). Especially history or presence of breast cancer, liver cancer, and suspected or confirmed prostate carcinoma. * History or current presence of prostate syndrome symptoms: frequent urination (both day and night), difficulty in starting urinati…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Urine concentration of bupropion metabolites

Timeframe: 0-4 h (hours), 4-8h, 8-12h, 12-24h, 24-48h and 48-72h post-administration

Urine concentration of anastrozole metabolites

Timeframe: 0-24 h (hours), 24-48h, 48-72h, 72-96h, 96-120h, 120-144h and 144-168h post-administration

Urine concentration of testosterone metabolites

Timeframe: 0-20 days post-administration (24-hour fractions)

Urine concentration of danazol metabolites

Timeframe: 0-4 h (hours), 4-8h, 8-12h, 12-24h, 24-36h and 36-48h post-administration

Urine concentration of chlorthalidone metabolites

Timeframe: 0-12 h (hours), 12-24h, 24-48h and 48-72h post-administration

Trial details

NCT IDNCT04757532

SponsorParc de Salut Mar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-10

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