Healthy VolunteersPhase 1FLUCNCT04201054
Generation of Biological Samples Positive to Fluconazole for Anti-Doping Control
A Phase 1 study testing Fluconazole in people with Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Fluconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSpain
- Study dates
- 25 Mar 2019to 5 Apr 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Healthy Volunteers
- Being tested
- Fluconazole
- Keywords
- Fluconazole, Anti-doping control, Athletic performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
50 mg of fluconazole administered orally in a single dose.
| Study group | Role | What they receive |
|---|---|---|
| Fluconazole | Experimental | 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). Receives: Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine concentration of fluconazole
Concentration of fluconazole in fraction-1 urine samples
Measured: 0-12 hours post-administration
Urine concentration of fluconazole
Concentration of fluconazole in fraction-2 urine samples
Measured: 12-24 hours post-administration
Urine concentration of fluconazole
Concentration of fluconazole in fraction-3 urine samples
Measured: 24-48 hours post-administration
Urine concentration of fluconazole
Concentration of fluconazole in fraction-4 urine samples
Measured: 48-72 hours post-administration
Secondary outcomes (4)
Urine concentration of fluconazole metabolites
Concentration of fluconazole metabolites in fraction-1 urine samples
Measured: 0-12 hours post-administration
Urine concentration of fluconazole metabolites
Concentration of fluconazole metabolites in fraction-2 urine samples
Measured: 12-24 hours post-administration
Urine concentration of fluconazole metabolites
Concentration of fluconazole metabolites in fraction-3 urine samples
Measured: 24-48 hours post-administration
Urine concentration of fluconazole metabolites
Concentration of fluconazole metabolites in fraction-4 urine samples
Measured: 48-72 hours post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start25 Mar 2019
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael de la Torre Fornell, Dr, Principal investigator, IMIM (Hospital del Mar Medical Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201054
- Sponsor's protocol ID
- IMIMFTCL/FLUC
- Acronym
- FLUC
- Status last verified
- Dec 2019
- First submitted
- 13 Dec 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Biological Samples Positive to Fluconazole for Anti-Doping Control
- ClinicalTrials.gov ID
- NCT04201054
- Acronym / sponsor ID
- FLUC / IMIMFTCL/FLUC
- Conditions
- Healthy Volunteers
- Keywords
- Fluconazole, Anti-doping control, Athletic performance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluconazole | Experimental | Drug: FluconazoleSubjects 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluconazole50 mg of fluconazole administered orally in a single dose. | Drug | Fluconazole |
Primary outcome
Urine concentration of fluconazole
Time frame: 0-12 hours post-administration
Concentration of fluconazole in fraction-1 urine samples
Urine concentration of fluconazole
Time frame: 12-24 hours post-administration
Concentration of fluconazole in fraction-2 urine samples
Urine concentration of fluconazole
Time frame: 24-48 hours post-administration
Concentration of fluconazole in fraction-3 urine samples
Urine concentration of fluconazole
Time frame: 48-72 hours post-administration
Concentration of fluconazole in fraction-4 urine samples
4 secondary outcomes
Urine concentration of fluconazole metabolites
Time frame: 0-12 hours post-administration
Urine concentration of fluconazole metabolites
Time frame: 12-24 hours post-administration
Urine concentration of fluconazole metabolites
Time frame: 24-48 hours post-administration
Urine concentration of fluconazole metabolites
Time frame: 48-72 hours post-administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael de la Torre Fornell, Dr principal investigator
IMIM (Hospital del Mar Medical Research Institute)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluconazole in people with Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine concentration of fluconazole (time frame: 0-12 hours post-administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.