NCT04197622

Generation of Biological Samples Positive to Hydrochlorothiazide for Anti-doping Control

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Background: Hydrochlorothiazide is a diuretic that inhibits the reabsorption of sodium and chloride in the renal tubules, thus increasing the excretion of water. The use of hydrochlorothiazide in athletes is prohibited by the World Anti-Doping Agency. Its fraudulent administration can lead to significant acute weight losses (body water reduction) and can mask the use of other doping substances, since it increases the urine volume and alters its pH (false negatives). The main degradation product of hydrochlorothiazide is 4-amino-6-chloro-1,3-benzenedisulfonamide (ACB). ACB is detectable in urine for a longer time and in a greater concentration than hydrochlorothiazide. This suggests that ACB may be an important marker for the detection of hydrochlorothiazide doping. 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 hydrochlorothiazide in urine for anti-doping control samples. Secondary objectives: To identify hydrochlorothiazide 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 (hydrochlorothiazide) administered in a single oral dose to 3 subjects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Hydrochlorothiazide	12,5 mg of hydrochlorothiazide (1/2 tablet of 25 mg) administered orally in a single dose.

Timeline

• Start date: 2019-03-05
• Primary completion: 2019-03-21
• Completion: 2019-03-21
• First posted: 2019-12-13
• Last updated: 2019-12-13

Locations

1 site across 1 country: Spain