Healthy VolunteersPhase 1ESPAMANCT04757532
Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers.
A Phase 1 study testing Bupropion, Anastrozole and Testosterone cyclopentylpropionate in people with Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Bupropion, Anastrozole and Testosterone cyclopentylpropionate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSpain
- Study dates
- 3 Dec 2020to 10 Mar 2021
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 urination, weak or discontinuous urinary stream, feeling of incomplete bladder emptying, or benign prostatic hyperplasia diagnosis.
- Levels of prostate specific antigen (PSA) out of normal range for subject's age, in those receiving anastrozole, testosterone or danazol.
- Clinical background or evidence of gastrointestinal, hepatic, renal disorder or others that may involve an alteration of the absorption, distribution, metabolism or excretion of the drug.
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- Clinical background or evidence of psychiatric disorders, alcoholism, drug abuse or habitual consumption of psychoactive drugs.
- Having participated in another clinical trial with medication in the three months prior to the start of the study.
- Having suffered some organic disease or major surgery in the six months prior to the start of the study.
- Clinical background or 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/her, may pose a risk to the subjects or may interfere with the objectives of the study. Especially history of venous thrombosis or thromboembolic disorders, thrombophilic alteration, edema, hypercalcemia, polycythemia, nephrosis, liver disease with altered liver function tests and porphyria.
- Having taken medication regularly in the month prior to the study sessions, including vitamins, herbal remedies or dietary supplements. Treatment with a single dose of symptomatic medication in the week prior to the study sessions will not be a reason for exclusion if it is assumed that the drug has been completely eliminated on the day of the experimental session.
- Smokers of more than 20 cigarettes a day in the 3 months before the study.
- Consumption of more than 40 g of alcohol daily.
- Consumers of more than 5 coffees, teas, cola drinks, or other stimulant drinks or with xanthines daily in the 3 months prior to the study start.
- Being unable to understand the nature, consequences of the trial and the procedures that are asked to follow.
- Positive serology for hepatitis B, C or HIV.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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).
- Conditions
- Healthy Volunteers
- Being tested
- Bupropion, Anastrozole, Testosterone cyclopentylpropionate, Danazol, Chlorthalidone
- Keywords
- Anti-doping control, Bupropion, Anastrozole, Danazol, Chlorthalidone, Testosterone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Elontril®
300 mg of bupropion hydrochloride (1 tablet) administered orally in a single dose.
AnastrozoleDrug
Also called Anastrozol Mylan®
1 mg of anastrozole (1 tablet) administered orally in a single dose.
Testosterone cyclopentylpropionateDrug
Also called Testex prolongatum®
100 mg of testosterone cyclopentylpropionate (equivalent to 70 mg of testosterone) administered via intramuscular injection in a single dose (2 mL).
DanazolDrug
Also called Danatrol®
200 mg of danazol (1 capsule) administered orally in a single dose.
ChlorthalidoneDrug
Also called Higrotona®
50 mg of chlorthalidone (1 tablet) administered orally in a single dose.
| Study group | Role | What they receive |
|---|---|---|
| Bupropion | Experimental | 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. Receives: Drug: Bupropion |
| Anastrozole | Experimental | 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. Receives: Drug: Anastrozole |
| Testosterone cyclopentylpropionate | Experimental | 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. Receives: Drug: Testosterone cyclopentylpropionate |
| Danazol | Experimental | 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. Receives: Drug: Danazol |
| Chlorthalidone | Experimental | 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. Receives: Drug: Chlorthalidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine concentration of bupropion metabolites
Concentration of bupropion metabolites in each fraction of urine samples
Measured: 0-4 h (hours), 4-8h, 8-12h, 12-24h, 24-48h and 48-72h post-administration
Urine concentration of anastrozole metabolites
Concentration of anastrozole metabolites in each fraction of urine samples
Measured: 0-24 h (hours), 24-48h, 48-72h, 72-96h, 96-120h, 120-144h and 144-168h post-administration
Urine concentration of testosterone metabolites
Concentration of testosterone metabolites in each fraction of urine samples
Measured: 0-20 days post-administration (24-hour fractions)
Urine concentration of danazol metabolites
Concentration of danazol metabolites in each fraction of urine samples
Measured: 0-4 h (hours), 4-8h, 8-12h, 12-24h, 24-36h and 36-48h post-administration
Urine concentration of chlorthalidone metabolites
Concentration of chlorthalidone metabolites in each fraction of urine samples
Measured: 0-12 h (hours), 12-24h, 24-48h and 48-72h post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start3 Dec 2020
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, non-randomized, unblinded, uncontrolled clinical trial in healthy male volunteers, at a single dose of the five study drugs (bupropion, anastrozole, testosterone cyclopentylpropionate, danazol and chlorthalidone).
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ana M Aldea Perona, MD PhD, Principal investigator, IMIM (Hospital del Mar Medical Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757532
- Sponsor's protocol ID
- IMIMFTCL/ESPAMA
- Acronym
- ESPAMA
- Status last verified
- Feb 2021
- First submitted
- 14 Feb 2021
- Last updated
- 26 Apr 2021
- 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 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Exposure to Substances Prohibited by the World Anti-Doping Agency in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT04757532
- Acronym / sponsor ID
- ESPAMA / IMIMFTCL/ESPAMA
- Conditions
- Healthy Volunteers
- Keywords
- Anti-doping control, Bupropion, Anastrozole, Danazol, Chlorthalidone, Testosterone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 17 Feb 2021 (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:
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Single-center, non-randomized, unblinded, uncontrolled clinical trial in healthy male volunteers, at a single dose of the five study drugs (bupropion, anastrozole, testosterone cyclopentylpropionate, danazol and chlorthalidone).
| Arm | Type | Receives |
|---|---|---|
| Bupropion | Experimental | Drug: BupropionSubjects 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. |
| Anastrozole | Experimental | Drug: AnastrozoleSubjects 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. |
| Testosterone cyclopentylpropionate | Experimental | Drug: Testosterone cyclopentylpropionateSubjects 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. |
| Danazol | Experimental | Drug: DanazolSubjects 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. |
| Chlorthalidone | Experimental | Drug: ChlorthalidoneSubjects 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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 urination, weak or discontinuous urinary stream, feeling of incomplete bladder emptying, or benign prostatic hyperplasia diagnosis.
- Levels of prostate specific antigen (PSA) out of normal range for subject's age, in those receiving anastrozole, testosterone or danazol.
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 |
|---|---|---|
| BupropionAlso: Elontril®300 mg of bupropion hydrochloride (1 tablet) administered orally in a single dose. | Drug | Bupropion |
| AnastrozoleAlso: Anastrozol Mylan®1 mg of anastrozole (1 tablet) administered orally in a single dose. | Drug | Anastrozole |
| Testosterone cyclopentylpropionateAlso: Testex prolongatum®100 mg of testosterone cyclopentylpropionate (equivalent to 70 mg of testosterone) administered via intramuscular injection in a single dose (2 mL). | Drug | Testosterone cyclopentylpropionate |
| DanazolAlso: Danatrol®200 mg of danazol (1 capsule) administered orally in a single dose. | Drug | Danazol |
| ChlorthalidoneAlso: Higrotona®50 mg of chlorthalidone (1 tablet) administered orally in a single dose. | Drug | Chlorthalidone |
Primary outcome
Urine concentration of bupropion metabolites
Time frame: 0-4 h (hours), 4-8h, 8-12h, 12-24h, 24-48h and 48-72h post-administration
Concentration of bupropion metabolites in each fraction of urine samples
Urine concentration of anastrozole metabolites
Time frame: 0-24 h (hours), 24-48h, 48-72h, 72-96h, 96-120h, 120-144h and 144-168h post-administration
Concentration of anastrozole metabolites in each fraction of urine samples
Urine concentration of testosterone metabolites
Time frame: 0-20 days post-administration (24-hour fractions)
Concentration of testosterone metabolites in each fraction of urine samples
Urine concentration of danazol metabolites
Time frame: 0-4 h (hours), 4-8h, 8-12h, 12-24h, 24-36h and 36-48h post-administration
Concentration of danazol metabolites in each fraction of urine samples
Urine concentration of chlorthalidone metabolites
Time frame: 0-12 h (hours), 12-24h, 24-48h and 48-72h post-administration
Concentration of chlorthalidone metabolites in each fraction of urine samples
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 26 Apr 2021.
- 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.
Ana M Aldea Perona, MD PhD 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 Bupropion, Anastrozole and Testosterone cyclopentylpropionate 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 16 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 26 Apr 2021. 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 bupropion metabolites (time frame: 0-4 h (hours), 4-8h, 8-12h, 12-24h, 24-48h and 48-72h post-administration). The study lists 5 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 26 Apr 2021.