Generation of Biological Samples Positive to Fluconazole for Anti-Doping Control (FLUC)

December 13, 2019 updated by: Parc de Salut Mar

Background:

Androgens are used for doping purpose because they can increase muscle mass and strength. These drugs are included in the list of prohibited substances of the World Anti-Doping Agency (WADA). The prohibition of its use has given rise to a great variety of strategies, including indirect androgenic doping (increasing endogenous testosterone production) or masking of exogenous testosterone administration.

Fluconazole is an imidazole antifungal that inhibits certain cytochrome P-450 dependent enzymes participating in the synthesis of steroid hormones. Concomitant fraudulent administration of testosterone and fluconazole may cause lower steroid concentrations in urine, leading to false negatives in the doping control. Thus, fluconazole may be used in athletes to mask exogenous steroid administration.

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 fluconazole in urine for anti-doping control samples.

Secondary objectives: To identify fluconazole 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 (fluconazole) administered in a single oral dose to 2 subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08003
        • IMIM (Hospital del Mar Medical Research Institute)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male volunteers aged between 18 and 45 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 at screening should be within normal limits. Minor or punctual variations of these limits of normality are admitted if, in the opinion of the Principal Investigator, they have no clinical significance, do not pose a risk to the subject and do not interfere with the evaluation of the product in study. These variations and their nonrelevance will be justified in writing specifically.
  • Body mass index (weight/size^2) between 19 and 25 kg/m2. Subjects with BMI between 25-27 kg/m2 may be included at the discretion of the Principal Investigator.

Exclusion Criteria:

  • Failure to meet the inclusion criteria.
  • History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance or any of the excipients.
  • History of serious adverse reactions to other medications.
  • Subjects with contraindications to treatment with the study drug (according to Summary of Product Characteristics).
  • Background or clinical evidence of psychiatric disorders, alcoholism, regular consumption of psychoactive drugs, drug abuse or addiction to other substances (except for nicotine).
  • Smokers of more than 20 cigarettes/day in the 3 months prior to the start of the study.
  • Having participated in another clinical trial with medication in the three months prior to the start of the study.
  • Having donated blood in the 2 months prior to the start of the study.
  • Having suffered an organic disease or major surgery in the 6 months prior to the start of the study.
  • Background or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematological, neurological, dermatological or other acute or chronic diseases that, in the opinion of the Principal Investigator or the collaborators designated by him, may pose a risk to the subjects, may interfere with the objectives of the study or may alter the pharmacokinetics of the drug. Especially in case of seizures or history of epilepsy.
  • Having taken medication regularly in the month prior to the study sessions, with the exception of vitamins, herbal remedies or dietary supplements that, in the opinion of the Principal Investigator or the collaborators designated by him, do not pose a risk to the subjects and do not interfere with the objectives of the study. Treatment with single doses of symptomatic medication in the week prior to the study sessions will not be exclusive if it is assumed that medication has been completely eliminated on the day of the experimental session.
  • Consumption of more than 40 g of alcohol per day.
  • Consumers of more than 5 coffees, teas, cola drinks and/or other stimulant drinks (xanthines) per day in the 3 months prior to the start of the study.
  • Being unable to understand the nature of the trial and the procedures requested to follow.
  • Positive serology for hepatitis B, C or HIV.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluconazole
Subjects receive a single-dose treatment.Urine samples will be collected after administration (4 fractions: 0-12, 12-24, 24-48, 48-72 hours post-administration).
50 mg of fluconazole administered orally in a single dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine concentration of fluconazole
Time Frame: 0-12 hours post-administration
Concentration of fluconazole in fraction-1 urine samples
0-12 hours post-administration
Urine concentration of fluconazole
Time Frame: 12-24 hours post-administration
Concentration of fluconazole in fraction-2 urine samples
12-24 hours post-administration
Urine concentration of fluconazole
Time Frame: 24-48 hours post-administration
Concentration of fluconazole in fraction-3 urine samples
24-48 hours post-administration
Urine concentration of fluconazole
Time Frame: 48-72 hours post-administration
Concentration of fluconazole in fraction-4 urine samples
48-72 hours post-administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine concentration of fluconazole metabolites
Time Frame: 0-12 hours post-administration
Concentration of fluconazole metabolites in fraction-1 urine samples
0-12 hours post-administration
Urine concentration of fluconazole metabolites
Time Frame: 12-24 hours post-administration
Concentration of fluconazole metabolites in fraction-2 urine samples
12-24 hours post-administration
Urine concentration of fluconazole metabolites
Time Frame: 24-48 hours post-administration
Concentration of fluconazole metabolites in fraction-3 urine samples
24-48 hours post-administration
Urine concentration of fluconazole metabolites
Time Frame: 48-72 hours post-administration
Concentration of fluconazole metabolites in fraction-4 urine samples
48-72 hours post-administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rafael de la Torre Fornell, Dr, IMIM (Hospital del Mar Medical Research Institute)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2019

Primary Completion (Actual)

April 5, 2019

Study Completion (Actual)

April 5, 2019

Study Registration Dates

First Submitted

December 13, 2019

First Submitted That Met QC Criteria

December 13, 2019

First Posted (Actual)

December 16, 2019

Study Record Updates

Last Update Posted (Actual)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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