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

(ESPAMA Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ana M Aldea Perona, MD PhD

Age: 18 - 65

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Parc de Salut Mar

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

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.

Participant Groups

Group I: Testosterone cyclopentylpropionate Experimental Treatment 1 Intervention

Subjects receive a single-dose treatment. Urine samples will be collected until 20 days after administration in 20 fractions: first urine of the day, every day.

Group II: Danazol Experimental Treatment 1 Intervention

Subjects receive a single-dose treatment. Urine samples will be collected until 2 days after administration in 6 fractions: 0-4h, 4-8h, 8-12h, 12-24h, 24-36h, 36-48h post-administration.

Group III: Chlorthalidone Experimental Treatment 1 Intervention

Subjects receive a single-dose treatment. Urine samples will be collected until 3 days after administration in 4 fractions: 0-12h, 12-24h, 24-48h y 48-72h post-administration.

Group IV: Bupropion Experimental Treatment 1 Intervention

Subjects receive a single-dose treatment. Urine samples will be collected until 3 days after administration in 6 fractions: 0-4h, 4-8h, 8-12h, 12-24h, 24-48h, 48-72h post-administration.

Group V: Anastrozole Experimental Treatment 1 Intervention

Subjects receive a single-dose treatment. Urine samples will be collected until 7 days after administration in 7 fractions: 0-24h, 24-48h, 48-72h, 72-96h, 96-120h, 120-144h, 144-168h post-administration.

Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Arimidex for:

• Breast cancer
• Early breast cancer in postmenopausal women

🇺🇸 Approved in United States as Arimidex for:

• Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
• First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer

🇨🇦 Approved in Canada as Arimidex for:

• Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
• Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer

🇯🇵 Approved in Japan as Arimidex for:

• Breast cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Who Is Running the Clinical Trial?

Parc de Salut Mar Lead Sponsor

References