There Are no Conditions Under Study. Healthy VolunteersPhase 1NCT02920359
Generation of Positive Biological Samples to Leuprolide Acetate for Doping Control
A Phase 1 study testing LEUPRORELIN ACETATE in people with There Are no Conditions Under Study. Healthy Volunteers, run by Parc de Salut Mar.
Trial summary
The study consists of the generation of biological samples (in urine) positive to leuprorelin acetate for doping control by new developed methods, and establish the analytical parameters that reveal the administration of Leuprorelin acetate in healthy volunteers with these methods. 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
- There Are no Conditions Under Study. Healthy Volunteers
- What is being tested?
- LEUPRORELIN ACETATE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 17 Nov 2016to 30 Sep 2017
- 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
- Healthy male volunteers aged from 18 to 45 years.
- Understanding and accepting the study procedures and signing the informed consent form.
- A health profile devoid of organic or physiological disorders.
- The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
- Body mass index (BMI=weigh/height2) will range between 19 and 25 Kg/m2 and weight between 50 and 100 kg. BMI between 25 and 27 kg/m2 can be included by principal investigator criteria.
Who cannot join
- Non compliance of the inclusion criteria.
- History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance, similar nonapeptides or any excipients.
- History of allergy or adverse reactions to any medication.
- Subjects for which the drug involved in the study is counter indicated.
- History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
- History or clinical evidence of alcoholism, drug abuse, or regular use of psychoactive drugs.
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- Have been volunteer in another study with drugs in the last 3 months prior to start this study.
- Have taken part in studies with blood donation in the last 2 months prior to start this study.
- Having suffered any organic disease or major surgery in the six months prior to start this study.
- A prior history of or presence of significant cardiovascular, neurological, haematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease that, in the investigator's opinion, considering the current state of the art, they are clinically significant, are life-threatening for the subjects and could interfere with the product assessment. Especially seizures or a history of epilepsy.
- Regular use of any drug in the month prior to the study sessions, except for vitamins, herbal remedies or dietary supplements if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
- Smokers of more than 20 cigarettes per day in the last 3 months prior to start this study.
- Taking more than 40 g of alcohol per day.
- Drinking more than 5 cups per day of coffee, tea, coke, stimulants or equivalent, or drinks containing xanthines, in the 3 months prior to start this study.
- Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
- Subjects with positive serology for hepatitis B, C or HIV.
- Subjects with anormal values of testosterone or prostate-specific antigen according to age normal values.
About this study
The study consists of the generation of biological samples (in urine) positive to leuprorelin acetate for doping control by new developed methods, and establish the analytical parameters that reveal the administration of Leuprorelin acetate in healthy volunteers with these methods.
- Being tested
- LEUPRORELIN ACETATE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEUPRORELIN ACETATEDrug
| Study group | Role | What they receive |
|---|---|---|
| LEUPRORELIN ACETATE | Experimental | Not described Receives: Drug: LEUPRORELIN ACETATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine concentrations of leuprorelin acetate
Urine samples will be collected in two intervals after the administration of leuprorelin acetate (0-3h; 3-6h) in all experimental study sessions (3 consecutive days).
Measured: From the administration to 6 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 posted30 Sep 2016 (estimated)
- Study start17 Nov 2016
- Primary completion13 Dec 2016
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for There Are no Conditions Under Study. 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael de la Torre, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920359
- Sponsor's protocol ID
- IMIMFTCL/LEUPRO
- Other IDs
- 2016-002719-16, 2016
- Status last verified
- Oct 2017
- First submitted
- 29 Sep 2016
- Last updated
- 6 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Positive Biological Samples to Leuprolide Acetate for Doping Control
- ClinicalTrials.gov ID
- NCT02920359
- Acronym / sponsor ID
- IMIMFTCL/LEUPRO
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 17 Nov 2016 (actual)
- Primary completion
- 13 Dec 2016 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 30 Sep 2016 (estimated)
- 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.
The study consists of the generation of biological samples (in urine) positive to leuprorelin acetate for doping control by new developed methods, and establish the analytical parameters that reveal the administration of Leuprorelin acetate in healthy volunteers with these methods.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEUPRORELIN ACETATE | Experimental | Drug: LEUPRORELIN ACETATE |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male volunteers aged from 18 to 45 years.
- Understanding and accepting the study procedures and signing the informed consent form.
- A health profile devoid of organic or physiological disorders.
- The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
- Body mass index (BMI=weigh/height2) will range between 19 and 25 Kg/m2 and weight between 50 and 100 kg. BMI between 25 and 27 kg/m2 can be included by principal investigator criteria.
Key exclusion criteria (17 listed)
- Non compliance of the inclusion criteria.
- History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance, similar nonapeptides or any excipients.
- History of allergy or adverse reactions to any medication.
- Subjects for which the drug involved in the study is counter indicated.
- History or clinical evidence of gastrointestinal, liver, renal or other disorders which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
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 |
|---|---|---|
| LEUPRORELIN ACETATE | Drug | LEUPRORELIN ACETATE |
Primary outcome
Urine concentrations of leuprorelin acetate
Time frame: From the administration to 6 hours post-administration
Urine samples will be collected in two intervals after the administration of leuprorelin acetate (0-3h; 3-6h) in all experimental study sessions (3 consecutive days).
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 6 Oct 2017.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LEUPRORELIN ACETATE in people with There Are no Conditions Under Study. Healthy Volunteers, run by Parc de Salut Mar.
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 17 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 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 concentrations of leuprorelin acetate (time frame: From the administration to 6 hours post-administration). 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 6 Oct 2017.